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Oral steroids and cough

Results can have a substantial impact on the well-being and management of these patients in Switzerland and beyond. An evidence-based treatment for this condition may reduce re-consultations with GPs and spending for antitussive drugs, thus possibly having an impact on health care spending. Prospectively registered on 18 January Peer Review reports. Cough as a symptom of respiratory infections is frequent in primary care and is one of the most common causes to seek medical advice in general practices GP [ 1 ].

Cough after an upper respiratory tract infection can be very bothersome and disabling in daily activities and has a significant impact on physical and psycho-social health, leading to impairment in quality of life QoL [ 2 ]. Recommendations for the management of post-infectious cough in general practice are scarce and inconsistent [ 3 , 4 ].

A previous systematic review and meta-analysis of randomized controlled trials RCT carried by our group provided a wide overview of treatment options for primary care patients with post-infectious cough and examined the patient-relevant benefits and potential harms of available therapies [ 7 ].

The review found only six RCTs assessing diverse treatment regimens, such as inhaled fluticasone propionate, inhaled budesonide, salbutamol plus ipratropium-bromide, montelukast, nociception-opioidreceptor agonist, codeine and gelatine. Most of the studies included in the review had an unclear or high risk of bias [ 7 ].

Two RCTs assessed inhaled corticosteroids for post-infectious cough [ 8 , 9 ]. Pornsuriyasak et al. The trial by Ponsioen et al. Clinical guidelines and recommendations on the use of inhaled corticosteroids are unclear [ 3 , 4 , 10 ]. A Cochrane review published in evaluated studies in which inhaled corticosteroids were tested in individuals with post-infectious or chronic cough [ 11 ].

A majority of the studies focused on patients with chronic cough and only two examined the benefits for post-infectious cough [ 11 ]. The authors concluded that no recommendation can be proposed due to the high heterogeneity and inconsistency of the studies and their results [ 11 ].

Additionally, an RCT in family practices in England found no benefit in terms of duration or severity of cough after a 5-day treatment with oral corticosteroids compared to placebo for adult patients with acute lower respiratory tract infection and without asthma [ 12 ]. Another RCT assessed the effectiveness of oral corticosteroids for patients with acute sore throat, Many of the symptoms in post-infectious cough are thought to be mediated by inflammatory processes that are also present in exacerbations of asthma or COPD [ 5 , 6 ].

However, at present, there is no established evidence-based treatment option for post-infectious cough, despite it being a very frequent condition. There is also considerable uncertainty regarding patient benefits from using inhaled or oral corticosteroids. The systematic search of our group did not identify any published RCT that assessed short-term use of oral corticosteroids for post-infectious cough [ 7 ] we updated our search in October and still found no pertinent trial.

We screened multiple study registries using the International Clinical Trials Registry Platform from the World Health Organization last search June and again found no trial investigating the use of oral corticosteroids for post-infectious cough.

A well-conducted randomized placebo-controlled trial is needed to determine the benefits and harms of using oral corticosteroids to treat post-infectious cough in patients in primary care. This randomized placebo-controlled trial aims to assess whether the benefits and harms of a 5-day prednisone treatment differ from those of a 5-day course of placebo. We designed a protocol for a randomized, parallel-group, placebo-controlled, triple-blinded, multicentred superiority trial in a primary health care setting, with blinded patients, physicians and outcome assessors.

Patients with post-infectious cough will be recruited by participating doctors in primary practices from cantons in the German-speaking part of Switzerland. Patient recruitment will continue until the sample size is reached. A list of the general practices currently taking part in the study can be obtained from the Sponsor-Investigator.

Known or suspected diagnoses associated with cough, such as pneumonia, allergic rhinitis, sinusitis, bronchial asthma, COPD, gastroesophageal reflux disease. Other chronic diseases such as bronchiectasis, cystic fibrosis, cancer, tuberculosis, heart failure. Regular treatment known to be associated with cough e. Uncontrolled diabetes mellitus as deemed by GPs who appraise whether the potential side effects of short-time corticosteroids on glucose levels exceed the hypothesized benefit on cough.

Patients with post-infectious cough presenting to their GP will be told about the OSPIC trial and provided with a study leaflet, participant information sheet and a consent form by their GP. They will be invited by the GP to take part after being given full written and verbal explanations of the trial purpose, potential benefits and risks and the procedures involved.

Those who agree to join the study will be asked to provide written consent and will be screened against the full eligibility criteria described above. Participants will have sufficient time to ask questions and GPs will make sure to underscore that participation is voluntary and that declining to join the study does not influence in any way the standard of care provided to patients. During the informed consent process with the GP, participants will be asked to give written permission for the storage and future use of the data resulted from the study.

Placebo pills are described in detail in the next section. Placebo will be used as a comparator in this study to prevent various biases in particular as the primary endpoint is patient-reported. Potential implications on a limited applicability of the results are acknowledged and will be discussed in the study results publication. From an ethical point of view, an inactive control placebo seems justified since there is no established therapy for post-infectious cough and because the symptoms resolve over time due to the natural course of the disease [ 7 , 12 ].

The placebo tablets match in appearance, diameter and height the intervention medication. Verbal and written instructions on how the drugs should be taken will be provided to the study participants. Even though the likelihood is very low, adverse events AE , such as allergic reactions to the study drug, psychotic or pre-psychotic episode, or serious adverse events SAE , sepsis, venous thromboembolism, fracture, can occur [ 17 ].

In any of these cases, the treatment will be stopped immediately. Medication will also be discontinued for other urgent reasons, such as pregnancy, a cancer diagnosis or an infection other than an upper respiratory tract infection. In order to facilitate adherence to the study intake schedule, participants are given a written medication guide. GPs will inform patients in depth on the importance to adhere to the 5-day medication for ensuring the effectiveness of treatment.

Furthermore, the dosing schedule is very convenient as the drugs need to be taken only once a day during breakfast and for a clearly defined and limited timeframe. In the event of a missed dose, patients are instructed to continue to take the medication the next day. Adherence to the study procedures will be checked at the follow-up phone call on day 7 from randomization when research staff will ask participants about their medication intake. In case the study medication is prematurely stopped or discontinued patients are asked to return the empty drug glass jars to their GP.

Apart from the use of corticosteroids, any co-treatment or co-medication i. Any other medical intervention used by study participants will be recorded in the electronic Case Report Forms eCRF to analyse the potential influence on outcomes. Treating doctors can independently decide to change to open-label treatment, adjust medication if they deem it necessary and for the benefit of their patients or choose additional therapeutic options. All participants will be asked at follow-up about concurrent medication, including if they started a treatment with antibiotics.

GPs and research staff are instructed to document time of onset, duration, resolution, actions to be taken, assessment of intensity and relationship with study treatment. Participants will be advised that they need to use contraceptives for the duration of the treatment and that they should inform the GP or the study team in case they suspect they have become pregnant. Women with anamnestic risk of a pregnancy unprotected sexual intercourse in the last 2 weeks shall be excluded from this study.

If a participant will become pregnant during follow-up, the participant will visit her gynaecologist. The GP will document the course and the outcome of the pregnancy. Total and individual LCQ domain scores will be calculated.

The LCQ is also suitable for capturing longitudinal developments in cough and cough-related well-being and can be useful in clinical trials assessing new medications for cough [ 20 ]. Appointments for the next phone calls will be set during the previous phone call and will assess:. Changes in glucose levels for patients with pre-study controlled diabetes that are deemed by GP to exceed the hypothesized benefit on cough.

Continuous outcomes will be assessed by comparing mean values. Medians will be considered in addition if we identify severe departures from normal distribution. Eligible patients who consent to the study will be randomly assigned by their GP to the active treatment or the control group. If performed, the GP will also record diagnostic test results.

Participants will be asked to complete the standardized LCQ questionnaire and hand it to the GP on day 0. Participants will also be informed about the follow-up calls and that the next telephone appointment will be at day 7 of the trial. After inclusion in the study, it is at the discretion of the treating GP to re-assess each participant at the general practice, when and as often as clinically needed. Physical examinations, lab testing, performing X-rays e.

In case participants are not reached at the first call, follow-up phone calls will be performed several times and participants will be sent reminders by email. Study schedule. To be able to detect an MCID of 1. Due to the fact that the number of recruited patients per GP is limited to 10, ICC might remain small. Sample size estimation was based on the assumption that individual LCQ scores are normally distributed.

Raj et al. A recent trial with a design and study population similar to ours reported a SD of 2. We decided to use the more conservative assumption of 3. A less conservative choice of an SD of 2. To compute the t test, the current version of the R language and environment R Foundation, www. In case of recruitment difficulties due to scheduled numbers of participants not being reached at predefined milestones, the limit of maximum of 10 randomized patients per GP can be increased.

To include participants, the recruitment period will cover two winter seasons when the incidence of upper respiratory tract infection is very high and post-infectious cough is very common. Even though coughing is prevalent throughout the year and patients can be affected in summer as well, we expect that most participants will be enrolled during the cold months.

If the enrolment goals are not met, the study will be submitted to other regional ethics committees in order to geographically expand the recruitment area. The randomization procedure will be implemented by the Clinical Trial Unit of the University Hospital Basel, which will generate a randomization list with a treatment allocation.

This list will be the basis for the University Hospital Basel Pharmacy to perform block randomization per practice, to label and to pack the study medication in glass jars. All GP practices will receive pre-randomized identically looking medication packages which will be handed to participants in the order of reception.

Following this procedure, participants will therefore be randomly allocated to either prednisone or placebo. With the randomization list being prepared by the CTU Basel and only accessible to the University Hospital Basel Pharmacy for preparing the sequentially numbered medication packages, the treatment allocation is concealed from patients, physicians, outcome assessors and other involved personal.

Participants will be enrolled by the GPs and will be assigned to the intervention randomly. GPs will distribute the randomized medication in the pre-established order set by the University Pharmacy Basel. Participants are required to return unused investigational treatments to their GPs.

All GPs, clinical investigators, outcome assessors and research staff involved in the study, as well as all patients, will remain blinded with respect to the randomization throughout the trial. In case participants require hospitalizations or they consult a different doctor not their GP , they are encouraged to take the medication guide with them.

GPs will not have access to the randomization list and in case of urgency, they have to make an unblinding request with the OSPIC study team. The GP will record individual socio-demographic characteristics and medical history, including age, sex, smoking behaviour, information on household smoking, symptoms, current treatment and doctor consultations.

If performed, the GP will also record diagnostic test results such as CRP test, white blood cell count, body temperature, blood pressure, pulse, oxygen saturation, previous or present X-Ray, previous or present lung function assessments. It has a total score addition of domain scores that ranges from 3 to 21 points, with a higher score corresponding to better health status [ 19 , 20 , 21 ].

The LCQ has already been used in a similar randomized-controlled trial assessing the effectiveness of montelukast in the treatment of post-infectious cough [ 24 ]. It is short, easy to administer and assesses the impact of cough on various aspects of life, including emotions, sleeping behaviour, work and relationships. The LCQ contains 19 items divided over 3 domains: physical 8 items , psychological 7 items and social 4 items ; with a 7-point Likert scale [ 19 , 20 ].

Participants will complete the LCQ on paper at baseline and over the telephone at follow-up. We will use the validated German version of the original LCQ [ 18 ]. If patients prematurely stop the study or do not answer the follow-up call, the study team can contact the GP to ask about possible GP visits, AE or SAE or hospitalizations i. Data will be collected until the time of withdrawal and will be analysed in the intention to treat analysis.

Direct access to source documents will be permitted for purposes of monitoring, audits and inspections. Study data entered in the eCRF are only accessible to authorized persons and an integrated audit trail will maintain a record of initial entries and any changes made, time and date of entry and user name of the person authorizing the entry or change.

All study data will be coded by the GP, stored and analysed in a coded manner. Password protection and user right management is used for the eCRF and ensures that only authorized study personal, data managers and local authorities, when permissible by law and necessary, will have access to the data during and after the study. Participant contact information will be collected for carrying follow-up calls and will be filled in the paper CRF form by the GP.

Participant lists will be kept at the GP practices for the entire duration of the study. All involved parties must keep the participant data strictly confidential. Detailed description of analyses will be defined in a statistical analysis plan SAP before unblinding the trial. Analysis of the primary objective will follow the intention-to-treat ITT principle. It will be based on the full analysis set FAS which will include all patients who were randomized and gave informed consent.

Patient data will be analysed according to their treatment allocation. A treatment effect of 1. Baseline characteristics of patients in the FAS will be presented stratified by group and summarized in a table. To assess the robustness of our primary analysis, an analysis of the primary outcome without imputing data complete case analysis will be performed. In order to estimate the effect of fully adhering to the study protocol, an analysis of the primary outcome using the per-protocol data set PPS, including all patients with full i adherence to the allocated 5-day treatments took all doses as defined in the study protocol and ii complete primary outcome and LCQ [ 18 , 20 ] score at baseline will be conducted.

We will also explore interactions between covariates of the ANCOVA model of the primary analysis and how the effect of the intervention varies among GP practices. For this, a linear mixed-model with treatment group as a fixed-effect and GP practices as a random effect will be fit. We will conduct one subgroup analysis, comparing effects on the primary outcome in current smokers vs. Subgroup effects will be analysed by interaction tests and interpreted fully exploratory.

We expect that effects are more pronounced in non-smokers according to reports by Ponsioen et al. Protocol non-adherence and impact of missing data will be assessed using a dataset that includes all patients with full i adherence to the allocated 5-day treatments took all doses as defined by the study protocol and ii complete primary outcome and LCQ [ 18 , 20 ] score at baseline. We will consider adjustments for time-varying post-randomization confounding [ 34 ] which will be predefined in the statistical analysis plan.

The reason for missing data and whether it might be at-random or not will be examined according to the European Medicines Agency EMA guidelines [ 35 ]. Missing data of all variables that are used in the statistical model to test the hypothesis will be imputed. Data of all available variables will be used for imputation. The imputation procedure will be further defined in the SAP.

The full study protocol which was approved by the Ethics Committee for North-western and Central Switzerland is available in the Supplementary material. Metadata describing the type, size and content of the datasets will be shared along with the study protocol and eCRF in a public repository dataverse. Independent and external researchers from the study team can seek to access the data for reuse in other projects by submitting a study synopsis to the DFK curator at dkf.

It is the responsibility of those researchers to seek a new approval for future studies from the ethics committee. Andreas Zeller. This is an investigator-driven study conducted under the supervision of Prof. Andreas Zeller, Prof. Stefan Essig. Andreas Zeller is the Principal Investigator for the study and the main responsible for the entire project.

Leuppi and Dr. Essig are also responsible with overseeing the conduct of the study. The CTU at the University Hospital Basel is tasked with handling the data management system and performing monitoring activities. Andreas Zeller will be involved in every step connected to this study including being responsible for project development and implementation, obtaining the collaboration of general practices for recruitment and enrolment of participants, interpretation of data, writing of scientific papers and study reports, etc.

Potential side effects and complications from corticosteroid will be systematically recorded during the trial. A recently published retrospective cohort study showed that even a short time use of corticosteroids increases the incidence of severe adverse events such as sepsis or venous thromboembolism [ 25 ]. Participants will be informed and asked to immediately contact the GP or the study team in the event of any possible side-effects.

In case the GPs cannot be reached, participants should visit the nearest hospital. For safety reasons, the study team will inform the corresponding GP about every reported event to ensure patient follow-up is arranged as soon as possible.

GPs and research staff will be instructed to document time of onset, duration, resolution and actions to be taken, as well as an assessment of intensity and relationship of event with study treatment. The course and outcome of the pregnancy should be followed up carefully with the GP, and any abnormal outcome regarding the mother or the child should be documented and reported. All participating Investigators must also be informed by the Sponsor about all safety signals, including the occurrence of suspected unexpected serious adverse reactions.

SAE assessments will be carried according to the severity grading scale used for adverse events occurring during trials: grade 1—mild, grade 2—moderate, grade 3—severe, grade 4—life-threatening, grade 5—death [ 37 ]. An annual safety report based on information from all participating GP practices will be prepared by the Sponsor-Investigator and submitted every year for the duration of the study to the EKNZ and to Swissmedic.

Access to study documentation and data is allowed for the purposes of audit by regulatory authorities, which is independent from the investigators and Sponsor. Data and sites monitoring will be carried by the CTU of the University Hospital Basel according to the study monitoring plan.

Mandatory reporting to the EKNZ and the regulatory authority Swissmedic will be carried, and we will seek approval prior to implementing any changes to the research protocol or to research activities. We will report changes to eligibility criteria, outcomes and unanticipated problems involving risks to participants, including the planned or premature study end. All changes will have to be first approved by the Sponsor and then reported.

Necessary changes made to the protocol that are meant to eliminate apparent immediate risks to participants will be reported as soon as possible after they occur. After ethics review and prior to implementation, investigators will be informed in writing about any changes to protocol. Information in the trial registry entries will be kept up-to-date and completed with study results after the completion of the trial.

Study results will be published in a peer-reviewed medical journal, independent of the outcomes and conclusions. All results from this study will be published in aggregated and anonymized way. Manuscripts submitted for peer-review and presentations of any results will adhere to relevant reporting guidelines for publication as put forth by the EQUATOR-network [ 15 , 31 , 38 , 39 , 40 ]. Additionally, at the end of the study, the research team will also update the systematic review on treatments for subacute cough [ 7 ] to include the data from the OSPIC trial.

Cough is often a nonspecific symptom of respiratory disease requiring complex differential diagnosis strategies, which raise challenges for both physicians and patients [ 42 ]. A recent RCT reported the effectiveness of a chronic cough management algorithm in paediatric community care and its usefulness in easily identifying causes of chronic cough by using this tool.

Seeking medical advice for cough is the most common reason for presentation to primary care practices worldwide [ 1 ], and in the USA alone between and , there were around , general practitioner or outpatient setting visits made due to cough associated with a previous respiratory infection [ 44 ].

Post-infectious cough has a broad impact on personal health and well-being [ 2 ] and bears relevant socioeconomic costs. Physicians may experience pressure to prescribe antibiotics, despite no supporting recommendations for this course of treatment [ 4 ]. Inhaled corticosteroids and orally administered montelukast are available treatment options for post-infectious cough. In a study in general practice, no benefit from montelukast therapy was found in patients with post-infectious cough [ 24 ].

As of April , the Food and Drug Administration issued a fifth and its highest warning boxed warning for risk of neuropsychiatric events associated with montelukast [ 48 ]. As there is no established evidence-based treatment option for this very frequent condition in primary care, only a well-conducted randomized placebo-controlled trial can determine a safe and efficient therapy.

Our study aims to fill this gap by determining the benefits and harms of oral corticosteroids in the treatment of patients with post-infectious cough enrolled in an RCT carried in a primary care setting. We selected prednisone for this trial because it is a well-established oral treatment for asthma, different allergic and other respiratory conditions [ 49 ]. Additionally, it is a low-cost therapy and proving its effectiveness and safety has significant cost reduction implications for treating cough.

The first reported case in Switzerland was at the end of February and was followed by extreme public health measures to stop the spread. At the same time, research activities, administrative services and management for clinical studies are severely impacted by this public health emergency. New clinical studies were suspended, running trials were halted and research reviews prioritized protocol submissions on SARS-CoV-2 [ 50 ]. Assessing the pandemic situation over the summer and early autumn, we decided to open the GP practices recruitment by end of September Provided that researchers strictly adhere to hygiene measures, the University of Basel encouraged the research teams to resume study activities in July We did not change the schedule of the follow-up visits.

There are limitations to this trial. We use a self-reporting tool the LCQ to measure cough-related quality of life and cough resolution, which is a subjective measurement. The mean SD symptom severity score between days 2 and 4 taken from the same trial was estimated as 2. Using standard formulae for the mean and standard deviation of a log-normal distribution, this corresponds to 1. Therefore, since duration of cough lasts significantly longer than the period during which severity of symptoms are measured days 2 to 4 and is capturing an element of the illness severity, duration of moderately bad or worse cough might be viewed as the slightly more clinically important outcome.

Hence a total sample size of is required. The trial team will make all efforts to recruit the participants. If recruitment is slower than anticipated, recruitment will be extended until at least have been recruited to each arm in total. Placebo tablets will be manufactured by Piramal Healthcare Ltd Morpeth UK to exactly match the prednisolone tablets in dimensions, appearance and taste, to maintain allocation blinding.

A minimum of 60 GP practices will be recruited to take part in the trial across the four trial centres, with a wide geographical spread in both urban and rural areas across the South West, Midlands and North West of England. The number recruited will take account of anticipated ready to recruit open to actually recruiting active ratios.

If the patient is willing, the clinician will screen the patient for eligibility. The routine clinical management of the patient will be completed as normal. A requirement for immediate antibiotic treatment renders the patient ineligible. The patient is then referred to a further interview for full recruitment and trial entry. The recruitment interview must take place on the same, or next, day as the routine consultation. Same-day recruitment will be more efficient for many patients who may not wish to return to the GP practice again the following day.

Same-day recruitment will also help ensure that participants take the first dose of their trial medication prior to collecting any delayed antibiotic that may have been prescribed for them by their GP, thereby ensuring the validity of antibiotic consumption as one of the secondary outcome measures. Some patients may wish to start taking a treatment on the same day that they visit the GP practice, and in the absence of a trial treatment those patients may be more likely to take antibiotics obtained from a delayed prescription or visited another healthcare provider while waiting for the next day to enter the trial.

However, if the site or patient do not have time for the recruitment interview on the same day, the patient can be recruited on the following working day, if the following conditions are met: the recruitment interview is not deferred to the Monday following a weekend, to reduce the possibility of recruiting patients whose clinical condition has deteriorated significantly since the eligibility assessment was performed; and any delayed antibiotic prescription is post-dated by at least 24 hours after the recruitment interview, to ensure that the patient has the opportunity to take the first dose of their trial medication prior to collecting their delayed antibiotic prescription.

The Recruiting Clinician will take formal written consent, collect the remaining CRF data including symptoms, signs and respiratory history , issue the patient with the trial medicines and explain how to take them. The patient will also receive a symptom diary, peak flow meter and other materials to fully equip them for the follow-up, and training in how to measure peak expiratory flow and complete the diary.

All follow-up will be managed by the trial team, who will give participants individual support throughout their follow-up period. Participants will complete the symptom diary online or on paper every day for up to 28 days or until symptoms have been completely resolved for two consecutive days whichever is soonest. As well as recording the severity of their symptoms, completing the symptom diary includes recording peak flow measurements and whether or not any antibiotics have been taken.

The patient will also record how many of the trial tablets they took on days 1 to 5, and any adverse effects during the first 7 days. All participants will be telephoned within the first 2 days of trial entry, and then each week for 4 weeks to support symptom diary completion, collect the daily data they have recorded during the preceding week to safeguard against potential loss of data if paper diaries are not returned to the trial centre or there are problems with the post , and to collect the weekly data on resource use and quality of life measures.

The patient will not be asked to complete any further trial paperwork after the initial 28 day period. This data collection will take place at least 4 months after randomisation to allow for secondary care contacts and test results to be evident in the primary care notes. See Figure 1 study flow chart for a visual representation of the pathway of the trial participant through the trial presentation, index consultation, baseline recruitment interview, and follow-up. Study flow chart. A visual representation of the pathway of the trial participant through the trial presentation, index consultation, baseline recruitment interview, and follow-up.

Clinical data will be collected and managed using a secure, web-based system OpenClinica which will be developed, hosted and supported by the University of Oxford and validated by the University of Bristol. Patient confidentiality will be maintained at all stages of data collection.

Participants will also be given the choice between online and paper data collection: the symptom diary will be made available online, with the exception of the EQ-5D-5L which will be completed by the patient on paper and also collected by the Trial Research Nurse during the weekly telephone calls.

Descriptive analyses will examine the comparability of the intervention and control group at baseline. The primary comparative analysis will be conducted on an intention-to-treat ITT basis. For the primary analysis missing data will be assumed to be missing at random and excluded from the analysis. Duration of cough is calculated as the number of days from the index consultation to the last day that the patient scored 3 or higher, where that last day is followed by at least two consecutive days with a score of less than 3.

Cox proportional hazards models adjusting by centre will be employed to examine differences in time to recovery from moderately bad to worse cough between the two groups. Individuals not recovered at 28 days post-randomisation will be censored at this time point. The assumption of proportional hazards will be checked using Schoenfeld residuals. Multiple linear regression models adjusting for centre will evaluate the effectiveness of steroids in terms of reducing symptom severity the mean score of six symptoms on days 2 to 4.

For both primary outcomes models will also adjust for any covariates demonstrating imbalance between the groups at baseline. Factors associated with missing data such as demographics and values of primary and important secondary outcome variables at baseline will be explored and sensitivity analyses conducted including inverse probability weights or multiple imputation methods, depending on whether outcome data is partially or fully missing.

It is anticipated that not all participants will complete the full course of tablets; hence, in further sensitivity analysis a per-protocol analysis will be performed. The economic analysis will use patient level data on participant resource use over the 28 day period between randomisation and the final follow-up telephone call.

This will be compared with outcomes measured at the day follow-ups. The analysis will consider three perspectives: 1 the health care provider and personal and social services NHS and PSS ; 2 participants and their families, 3 societal cost of lost productivity due to time off work.

The costs associated with the NHS and PSS perspective will include: trial and prescription medication costs, and the costs associated with primary and secondary care consultations. Participant resource use will include travel to consultations, expenditure on over-the-counter medications, cost of extra domestic help and childcare, prescription payments, and loss of earnings.

We will use the data listed above to construct a cost-consequences matrix comparing cost from the three perspectives with the full range of primary and secondary outcomes. We will estimate incremental cost-effectiveness ratios comparing the extra cost, from the NHS perspective, of treating participants in the intervention group, with the extra benefit gained.

Sensitivity analyses will be used to test the robustness of the results against assumptions made and bootstrapping will be used to estimate the level of uncertainty around the estimates of cost per QALY. This paper describes a placebo-controlled, randomised multi-centre superiority trial that will establish the clinical and cost effectiveness of a commonly used treatment corticosteroids for an entirely novel indication and one of the commonest clinical problems managed in primary care: acute LRTI.

The trial will recruit between and non-asthmatic adult patients presenting to primary care with an acute cough of less than 28 days duration and at least one other lower respiratory tract symptom or physical examination finding. Participants will be telephoned weekly for 4 weeks, or until their cough resolves, up to a maximum of 8 weeks from recruitment. None of the sources of funding influenced either the trial design, the writing of the manuscript or the decision to submit the manuscript for publication.

Dr Birgit Whitman birgit. Competing interests. ADH is the Chief Investigator and guarantor of the trial, leads the development of the research question, trial design and implementation of the trial protocol for the investigative teams, and contributed to the drafting of the manuscript.

MVM and AH contributed to the development of the research question and the trial design and, as Principal Investigators, supervised the implementation of the trial protocol in the Southampton and Oxford centres, respectively. DK contributed to the development of the research question and the trial design, supervised the implementation of the trial protocol in the Nottingham centre as Principal Investigator, and contributed to the drafting of the manuscript.

PL and MT contributed to the development of the research question and the trial design. HED, the Trial Manager, coordinated the operational delivery of the trial protocol across the UK and contributed to the drafting of the manuscript. EO contributed to the trial design, to the supervision of trial implementation in the Nottingham centre, and to the drafting of the manuscript. DT co-ordinated the implementation of the trial in the Oxford centre and contributed to the drafting of the manuscript.

KW contributed to the trial design, to the supervision of trial implementation in the Oxford centre, and to the drafting of the manuscript. All authors listed provided critical review and final approval of the manuscript. Harriet E Downing, Email: ku.

Fran Carroll, Email: ku. Sara T Brookes, Email: ku. Sandra Hollinghurst, Email: ku. David Timmins, Email: ku. Elizabeth Orton, Email: ku. Kay Wang, Email: ku. Denise Kendrick, Email: ku. Paul Little, Email: ku. Mike V Moore, Email: ku. Anthony Harnden, Email: ku. Matthew Thompson, Email: ku. Margaret T May, Email: ku. Alastair D Hay, Email: ku. National Center for Biotechnology Information , U.

Journal List Trials v. Published online Mar 7. Author information Article notes Copyright and License information Disclaimer. Corresponding author. Received Sep 4; Accepted Jan This article has been cited by other articles in PMC. Abstract Background Acute lower respiratory tract infection LRTI is one of the most common conditions managed internationally and is costly to health services and patients.

Discussion Results from the OSAC trial will increase knowledge regarding the clinical and cost-effectiveness of corticosteroids for LRTI, and will establish the potential of a new treatment option that could substantially improve patient health. Electronic supplementary material The online version of this article doi Keywords: Acute cough, Lower respiratory tract infection, Oral steroids, Corticosteroids, Prednisolone, Randomised controlled trial, Efficacy, Cost-effectiveness.

Rationale for testing the effectiveness of corticosteroids in lower respiratory tract infection Symptoms of LRTI include cough, wheeze and shortness of breath, which are similar to the symptoms of exacerbated asthma [ 14 , 15 ]. Rationale for the trial design This double-blind randomised controlled trial will provide high quality evidence to determine whether steroids are effective in the symptomatic treatment of acute LRTI, for which, to date, non-steroidal anti-inflammatory drugs [ 13 ], antibiotics [ 9 ] and inhaled corticosteroids [ 6 ] have been shown to be ineffective.

Eligibility We wish to test the effects of corticosteroids in adults presenting to primary care with acute LRTI, in whom there is no evidence of pneumonia or other reason to require an immediate antibiotic or hospitalisation, and in whom there is no reason to consider the use of oral prednisolone 40 mg daily for 5 days unsafe. Treatment allocation, concealment and emergency unblinding The computer-generated randomisation schedule will be produced by a statistician who is independent of the OSAC trial statisticians, and stratified by centre using a variable block size.

Outcomes How the outcome measures will be ascertained The OSAC trial will use validated patient completed symptom diary methods [ 37 ] that have been used in a number of similar previous trials [ 2 , 5 ]. Duration is calculated as the number of days from randomisation to the last day that the participant scored 3 or higher, where that last day is followed by at least two consecutive days where the score is less than 3; Mean of all symptom severity scores on days 2 to 4 post randomisation, measured using the symptom diary.

Sample size calculation Since the distributions of both primary outcome variables the duration of moderately bad or worse cough and the mean severity score of all its associated symptoms on days 2 to 4 post-randomisation will be positively skewed, sample size calculations are based on the log-normal distribution. Recruitment sites A minimum of 60 GP practices will be recruited to take part in the trial across the four trial centres, with a wide geographical spread in both urban and rural areas across the South West, Midlands and North West of England.

Trial entry the recruitment interview The recruitment interview must take place on the same, or next, day as the routine consultation. Participant follow-up All follow-up will be managed by the trial team, who will give participants individual support throughout their follow-up period. Open in a separate window. Figure 1. Data management Clinical data will be collected and managed using a secure, web-based system OpenClinica which will be developed, hosted and supported by the University of Oxford and validated by the University of Bristol.

Analysis Descriptive analyses will examine the comparability of the intervention and control group at baseline. Economic analysis The economic analysis will use patient level data on participant resource use over the 28 day period between randomisation and the final follow-up telephone call. Discussion This paper describes a placebo-controlled, randomised multi-centre superiority trial that will establish the clinical and cost effectiveness of a commonly used treatment corticosteroids for an entirely novel indication and one of the commonest clinical problems managed in primary care: acute LRTI.

Trial sponsor Dr Birgit Whitman birgit. Footnotes Competing interests The authors declare that they have no competing interests. References 1. Reducing reconsultations for acute lower respiratory tract illness with an information leaflet: a randomised controlled study of patients in primary care.

Br J Gen Pract. Amoxicillin for uncomplicated acute lower respiratory tract infection in primary care when pneumonia is not suspected: a 12 country, randomised, placebo controlled trial. Initial antibiotic therapy for lower respiratory tract infection in the community: a European survey. Eur Respir J.

Variation in antibiotic prescribing and its impact on recovery in patients with acute cough in primary care: prospective study in 13 countries. Information leaflet and antibiotic prescribing strategies for acute lower respiratory tract infection: a randomised controlled trial. Corticosteroids for acute and subacute cough following respiratory tract infection: a systematic review. Fam Pract.

Measuring the financial burden of acute cough in pre-school children: a cost of illness study. BMC Fam Pract. Rates of sickness certification in European primary care: a systematic review. Eur J Gen Pract. Antibiotics for acute bronchitis Review; originally published in the Cochrane Library , Issue 3. Cochrane Database Syst Rev. Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta-analysis.

Antimicrobial resistance is a major threat to public health. Annual Report of the Chief Medical Officer, 2.

STEROIDS TO GAIN WEIGHT AND MUSCLE

Research and anecdotal evidence suggests that European clinicians have started prescribing corticosteroids for LRTI in the absence of chronic obstructive pulmonary disease COPD [ 29 ], even though there is limited evidence to support their use for this condition. Long-term steroid use is known to be associated with an array of unwanted systemic side effects such as adrenal suppression, impaired skin collagen synthesis and metabolic disturbances [ 30 , 31 ]. However, in the absence of specific contraindications [ 30 , 32 ], a short up to 1 week course of high-dose corticosteroids is considered to be safe and associated with few side effects [ 32 - 34 ].

The rationale for testing the effectiveness of corticosteroids in LRTI can be summarised as follows: i there is good evidence of oral steroid effectiveness for acute asthma; ii the symptoms of LRTI overlap with those of acute asthma; iii prednisolone tablets at a dose of 40 mg daily for 5 to 7 days is the most commonly used oral steroid for acute asthma; iv there is pharmacokinetic evidence to suggest that a minimum dose of 20 mg daily is required for non-asthmatic patients [ 35 ]; and v it is important that the first trial of its kind uses an adequate dose to detect any potential effects as a proof of concept.

This double-blind randomised controlled trial will provide high quality evidence to determine whether steroids are effective in the symptomatic treatment of acute LRTI, for which, to date, non-steroidal anti-inflammatory drugs [ 13 ], antibiotics [ 9 ] and inhaled corticosteroids [ 6 ] have been shown to be ineffective. A double-blinded, maximum dose design has been chosen since: i the primary outcomes are subjective in that cough severity is reported by the participant ; and ii treatment with this agent for this clinical problem is novel, making a trial demonstrating effectiveness under optimal conditions important.

In another study, participants reported symptoms between days 2 and 4 as being the worst problem [ 2 ], which provides the rationale for the timing for the second primary outcome in this trial. We recognise the undesirability of further medicalisation of common and self-limiting infections in primary care [ 36 ], and if this trial demonstrates a clinically important treatment effect, we do not think it will be appropriate to promote the routine use of high-dose corticosteroids for acute LRTI though we recognise that the prescription of corticosteroids to alleviate the most acute symptoms of chest infections remains a clinical decision.

Rather, we think the implication will be that further trials of lower-dose oral or inhaled corticosteroids should be conducted. If no treatment effect is found, it is unlikely that further, lower-dose steroid research would be warranted for acute LRTI. This study is a placebo-controlled, individually randomised, superiority trial in UK general practice. We wish to test the effects of corticosteroids in adults presenting to primary care with acute LRTI, in whom there is no evidence of pneumonia or other reason to require an immediate antibiotic or hospitalisation, and in whom there is no reason to consider the use of oral prednisolone 40 mg daily for 5 days unsafe.

At the same time, the relatively high dose used in this trial requires stringent exclusion criteria to ensure patient safety. The eligibility criteria are as follows:. In the past 24 hours, the patient has had at least one of the screening symptoms listed below a-d , localising to the lower respiratory tract and suggestive of an acute LRTI:.

Patient and practice have sufficient time for consent and randomisation into the trial by the end of the day of consultation, or the next working day as long as this is within 24 hours;. Patient able, willing and available to receive weekly telephone calls from the trial team. The presence of any of the following exclusion criteria warrants exclusion:. Known lung cancer or chronic lung disease for example, cystic fibrosis, COPD, bronchiectasis ;. According to NICE guidelines, the patient warrants immediate antibiotic treatment by virtue of one or more of the following:.

Is at high risk of complications, including patients with chronic heart, chronic lung for example, COPD, bronchiectasis and cystic fibrosis , chronic renal, chronic liver or neuromuscular disease or immunosuppression; or with complications from previous episodes of lower respiratory tract infection, for example hospital admission for pneumonia.

Aged over 65 years with at least two of the following criteria, or aged over 80 years with at least one of the following criteria:. Requires an oral or systemic antibiotic on the day of consultation to treat another infection unrelated to their acute cough, for example a co-existing cellulitis note: use of topical antibiotics does not preclude OSAC trial participation ;. Known to be pregnant, is trying to conceive or is at risk of pregnancy for example, unwilling to take a reliable form of contraception in the next month;.

Has been involved in another medicinal trial within the last 90 days or any other clinical research study within the last 30 days;. Is unable to give informed consent or complete the trial paperwork including the symptom diary through mental incapacity, for example major current psychiatric illness, learning difficulties and dementia;. Known immune-deficiency, for example chemotherapy causing immunosuppression, asplenia or splenic dysfunction, advanced cancer or HIV infection;.

Patient due to receive the shingles vaccine in conjunction with the influenza vaccine;. Known allergy to prednisolone or other OSAC trial tablet ingredients potato starch, lactose monohydrate, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate , galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Intention to use a live vaccine in the next 8 weeks or has received a live vaccine in the previous 2 weeks note: assess live vaccine status by cross-checking with the British National Formulary.

To meet the recruitment target and to ensure a generalisable patient population, recruitment will take place across four collaborating UK trial centres: the Universities of Bristol, Nottingham, Oxford and Southampton.

Participants may stop taking the trial medication before the 5 days if they feel completely better for two consecutive days. Participants, clinicians and the trial team including the statisticians will all be blinded to allocation.

All participants randomised to the trial will continue to receive usual clinical care. The computer-generated randomisation schedule will be produced by a statistician who is independent of the OSAC trial statisticians, and stratified by centre using a variable block size. Packs, which are indistinguishable between active and placebo groups, are issued sequentially to eligible, consented patients at recruiting primary care sites. Clinicians, patients and all members of the research team were masked to the randomisation sequence, and all outcome data were gathered masked to allocation status.

The use of distinct Participant ID and Medicine ID numbers will enable flexibility in the number of patients recruited at each of the four trial centres. Medicine packs can be combined with patient packs as needed, allowing for temporary differential fluctuations in recruitment rates between centres. The four centres will be provided with Patient Packs to distribute to the participating primary care sites in blocks of four although larger numbers of packs will be issued to practices with proven capacity to recruit to this trial.

The Pharmacy will hold the master drug allocation log and provide a 24 hour emergency unblinding service based on a standard operating procedure for breaking the code in the event of a medical emergency. Trial participants will be given a Trial Participation Card with details of who their Responsible Clinician should contact in the event of an emergency, and all practice-based clinicians will receive training in the use of the emergency unblinding service.

At the end of the trial, the code-break will only be released to the investigative team once written confirmation has been received that primary outcome data analysis is complete. The OSAC trial will use validated patient completed symptom diary methods [ 37 ] that have been used in a number of similar previous trials [ 2 , 5 ]. Participants will record in the diary the severity of the following symptoms: cough; phlegm; shortness of breath; sleep disturbance; feeling generally unwell; activity disturbance.

For this trial, we will record all the above symptoms for up to 28 days or until symptom resolution for two consecutive days since LRTI duration has been previously shown to last 3 to 4 weeks [ 5 ]. Cough duration and severity will be measured for up to 8 weeks since effects on these may not be apparent for some time after using corticosteroids.

Duration is calculated as the number of days from randomisation to the last day that the participant scored 3 or higher, where that last day is followed by at least two consecutive days where the score is less than 3;. Mean of all symptom severity scores on days 2 to 4 post randomisation, measured using the symptom diary.

Severity of symptoms is scored 0 to 6 as for cough, detailed above. A mean score will be calculated across these symptoms for each of days 2, 3 and 4 and then an overall mean calculated. Patient satisfaction with treatment and intention to use the same treatment if it were to be available in the future;. Clinical diagnosis of asthma, COPD, whooping cough pertussis , or lung cancer at 3 months;.

NHS treatment and investigation costs, out-of-pocket patient and family costs, and the cost to society of time off work. Since the distributions of both primary outcome variables the duration of moderately bad or worse cough and the mean severity score of all its associated symptoms on days 2 to 4 post-randomisation will be positively skewed, sample size calculations are based on the log-normal distribution.

The mean standard deviation SD duration of bad or moderately worse cough was taken from a previous study examining the effectiveness of prescribed antibiotics for acute LRTI [ 5 ] and estimated as 5. The mean SD symptom severity score between days 2 and 4 taken from the same trial was estimated as 2.

Using standard formulae for the mean and standard deviation of a log-normal distribution, this corresponds to 1. Therefore, since duration of cough lasts significantly longer than the period during which severity of symptoms are measured days 2 to 4 and is capturing an element of the illness severity, duration of moderately bad or worse cough might be viewed as the slightly more clinically important outcome.

Hence a total sample size of is required. The trial team will make all efforts to recruit the participants. If recruitment is slower than anticipated, recruitment will be extended until at least have been recruited to each arm in total. Placebo tablets will be manufactured by Piramal Healthcare Ltd Morpeth UK to exactly match the prednisolone tablets in dimensions, appearance and taste, to maintain allocation blinding. A minimum of 60 GP practices will be recruited to take part in the trial across the four trial centres, with a wide geographical spread in both urban and rural areas across the South West, Midlands and North West of England.

The number recruited will take account of anticipated ready to recruit open to actually recruiting active ratios. If the patient is willing, the clinician will screen the patient for eligibility. The routine clinical management of the patient will be completed as normal. A requirement for immediate antibiotic treatment renders the patient ineligible. The patient is then referred to a further interview for full recruitment and trial entry.

The recruitment interview must take place on the same, or next, day as the routine consultation. Same-day recruitment will be more efficient for many patients who may not wish to return to the GP practice again the following day. Same-day recruitment will also help ensure that participants take the first dose of their trial medication prior to collecting any delayed antibiotic that may have been prescribed for them by their GP, thereby ensuring the validity of antibiotic consumption as one of the secondary outcome measures.

Some patients may wish to start taking a treatment on the same day that they visit the GP practice, and in the absence of a trial treatment those patients may be more likely to take antibiotics obtained from a delayed prescription or visited another healthcare provider while waiting for the next day to enter the trial.

However, if the site or patient do not have time for the recruitment interview on the same day, the patient can be recruited on the following working day, if the following conditions are met: the recruitment interview is not deferred to the Monday following a weekend, to reduce the possibility of recruiting patients whose clinical condition has deteriorated significantly since the eligibility assessment was performed; and any delayed antibiotic prescription is post-dated by at least 24 hours after the recruitment interview, to ensure that the patient has the opportunity to take the first dose of their trial medication prior to collecting their delayed antibiotic prescription.

The Recruiting Clinician will take formal written consent, collect the remaining CRF data including symptoms, signs and respiratory history , issue the patient with the trial medicines and explain how to take them. The patient will also receive a symptom diary, peak flow meter and other materials to fully equip them for the follow-up, and training in how to measure peak expiratory flow and complete the diary. All follow-up will be managed by the trial team, who will give participants individual support throughout their follow-up period.

Participants will complete the symptom diary online or on paper every day for up to 28 days or until symptoms have been completely resolved for two consecutive days whichever is soonest. As well as recording the severity of their symptoms, completing the symptom diary includes recording peak flow measurements and whether or not any antibiotics have been taken. The patient will also record how many of the trial tablets they took on days 1 to 5, and any adverse effects during the first 7 days.

All participants will be telephoned within the first 2 days of trial entry, and then each week for 4 weeks to support symptom diary completion, collect the daily data they have recorded during the preceding week to safeguard against potential loss of data if paper diaries are not returned to the trial centre or there are problems with the post , and to collect the weekly data on resource use and quality of life measures. The patient will not be asked to complete any further trial paperwork after the initial 28 day period.

This data collection will take place at least 4 months after randomisation to allow for secondary care contacts and test results to be evident in the primary care notes. See Figure 1 study flow chart for a visual representation of the pathway of the trial participant through the trial presentation, index consultation, baseline recruitment interview, and follow-up. Study flow chart.

A visual representation of the pathway of the trial participant through the trial presentation, index consultation, baseline recruitment interview, and follow-up. Clinical data will be collected and managed using a secure, web-based system OpenClinica which will be developed, hosted and supported by the University of Oxford and validated by the University of Bristol.

Patient confidentiality will be maintained at all stages of data collection. Participants will also be given the choice between online and paper data collection: the symptom diary will be made available online, with the exception of the EQ-5D-5L which will be completed by the patient on paper and also collected by the Trial Research Nurse during the weekly telephone calls.

Descriptive analyses will examine the comparability of the intervention and control group at baseline. The primary comparative analysis will be conducted on an intention-to-treat ITT basis. For the primary analysis missing data will be assumed to be missing at random and excluded from the analysis. Duration of cough is calculated as the number of days from the index consultation to the last day that the patient scored 3 or higher, where that last day is followed by at least two consecutive days with a score of less than 3.

Cox proportional hazards models adjusting by centre will be employed to examine differences in time to recovery from moderately bad to worse cough between the two groups. Individuals not recovered at 28 days post-randomisation will be censored at this time point. The assumption of proportional hazards will be checked using Schoenfeld residuals.

Multiple linear regression models adjusting for centre will evaluate the effectiveness of steroids in terms of reducing symptom severity the mean score of six symptoms on days 2 to 4. For both primary outcomes models will also adjust for any covariates demonstrating imbalance between the groups at baseline. Factors associated with missing data such as demographics and values of primary and important secondary outcome variables at baseline will be explored and sensitivity analyses conducted including inverse probability weights or multiple imputation methods, depending on whether outcome data is partially or fully missing.

It is anticipated that not all participants will complete the full course of tablets; hence, in further sensitivity analysis a per-protocol analysis will be performed. The economic analysis will use patient level data on participant resource use over the 28 day period between randomisation and the final follow-up telephone call.

This will be compared with outcomes measured at the day follow-ups. The analysis will consider three perspectives: 1 the health care provider and personal and social services NHS and PSS ; 2 participants and their families, 3 societal cost of lost productivity due to time off work.

The costs associated with the NHS and PSS perspective will include: trial and prescription medication costs, and the costs associated with primary and secondary care consultations. Participant resource use will include travel to consultations, expenditure on over-the-counter medications, cost of extra domestic help and childcare, prescription payments, and loss of earnings.

We will use the data listed above to construct a cost-consequences matrix comparing cost from the three perspectives with the full range of primary and secondary outcomes. We will estimate incremental cost-effectiveness ratios comparing the extra cost, from the NHS perspective, of treating participants in the intervention group, with the extra benefit gained.

Sensitivity analyses will be used to test the robustness of the results against assumptions made and bootstrapping will be used to estimate the level of uncertainty around the estimates of cost per QALY. This paper describes a placebo-controlled, randomised multi-centre superiority trial that will establish the clinical and cost effectiveness of a commonly used treatment corticosteroids for an entirely novel indication and one of the commonest clinical problems managed in primary care: acute LRTI.

The trial will recruit between and non-asthmatic adult patients presenting to primary care with an acute cough of less than 28 days duration and at least one other lower respiratory tract symptom or physical examination finding. Participants will be telephoned weekly for 4 weeks, or until their cough resolves, up to a maximum of 8 weeks from recruitment. None of the sources of funding influenced either the trial design, the writing of the manuscript or the decision to submit the manuscript for publication.

Dr Birgit Whitman birgit. Competing interests. ADH is the Chief Investigator and guarantor of the trial, leads the development of the research question, trial design and implementation of the trial protocol for the investigative teams, and contributed to the drafting of the manuscript. MVM and AH contributed to the development of the research question and the trial design and, as Principal Investigators, supervised the implementation of the trial protocol in the Southampton and Oxford centres, respectively.

DK contributed to the development of the research question and the trial design, supervised the implementation of the trial protocol in the Nottingham centre as Principal Investigator, and contributed to the drafting of the manuscript. PL and MT contributed to the development of the research question and the trial design.

HED, the Trial Manager, coordinated the operational delivery of the trial protocol across the UK and contributed to the drafting of the manuscript. EO contributed to the trial design, to the supervision of trial implementation in the Nottingham centre, and to the drafting of the manuscript. DT co-ordinated the implementation of the trial in the Oxford centre and contributed to the drafting of the manuscript.

KW contributed to the trial design, to the supervision of trial implementation in the Oxford centre, and to the drafting of the manuscript. All authors listed provided critical review and final approval of the manuscript. Harriet E Downing, Email: ku. Fran Carroll, Email: ku. Sara T Brookes, Email: ku. Sandra Hollinghurst, Email: ku. David Timmins, Email: ku. Elizabeth Orton, Email: ku. For general information, Learn About Clinical Studies.

Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U.

Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Last Update Posted : December 2, See Contacts and Locations. Study Description. The purpose of this study is to assess whether a 5-day treatment with orally administered prednisone provides patient-relevant benefits by improving the cough-related QoL of patients with post-infectious cough triggered by an Upper Respiratory Tract Infection URTI and seeking care in adult primary care practices.

The study aims to describe an efficacy and safety profile for a 5-day prednisone treatment compared to a 5-day course of placebo. FDA Resources. Arms and Interventions. Outcome Measures. The LCQ is a validated QoL measurement tool for non-specific cough and assesses the impact of cough on various aspects of life, including emotions, sleeping behaviour, work and relationships.

It contains 19 items which are divided over 3 domains: physical 8 items , psychological 7 items and social 4 items , with a 7-point Likert response scale. Eligibility Criteria. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials. Layout table for location contacts Contact: Andreas Zeller, Prof. More Information. Publications automatically indexed to this study by ClinicalTrials. Oral corticosteroids for post-infectious cough in adults: study protocol for a double-blind randomized placebo-controlled trial in Swiss family practices OSPIC trial.

National Library of Medicine U.

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You should read the information leaflet that comes with your medicine packet for a full list of possible side-effects. The main possible side-effects include the following:. The above are only the main possible side-effects which may affect some people who take steroids.

There is often a balance between the risk of side-effects against the symptoms and damage that may result from some diseases if they are not treated. Some of the less common side-effects are not listed above but will be included on the leaflet that comes with your medicine.

There are very few people who cannot take oral corticosteroids. Only people who have serious infections and are not taking treatment for the infection should not take oral steroids. This is because steroids suppress your immune system, making you less likely to fight off the infection. If you have taken a short course of weeks of an oral steroid, you can simply stop taking the tablets at the end of the course. Do not stop taking oral steroids suddenly if you have been taking them for more than three weeks.

It probably does no harm to forget the odd dose. However, you may have serious withdrawal effects once your body is used to the steroids. These may develop within a few days if you stop oral steroids suddenly. Any change in dose should be supervised by a doctor. Any reductions in dose are done slowly, over a number of weeks. Your body normally makes steroid chemicals by itself which are necessary to be healthy.

When you take oral steroids for a few weeks or more, your body may reduce or stop making its own steroid chemicals. If you then stop taking oral steroids suddenly, your body does not have any steroids.

This can cause various withdrawal symptoms until your body resumes making natural steroids over a few weeks. The withdrawal symptoms can be serious, even life-threatening and include:. If the dose is reduced gradually, the body gradually resumes its natural production of steroids and the withdrawal symptoms do not occur.

Potentially, many other medicines can 'interact' with steroids. This means the steroid could affect how they work, either resulting in the other medicine being ineffective, or having more side-effects than usual. Or they can interact the other way around, with the other medicine affecting the corticosteroid. Doses may have to be adjusted accordingly in order for both medicines to be taken together. As long as your doctor knows you are taking this, they can advise accordingly.

Usually you can take both medicines, but you may need to be monitored for the effects. For example, you may need blood tests to check the combination is not causing any problems. Doses can then be adjusted as necessary. Your doctor will help you weigh up the pros and cons but, generally speaking, steroids can usually be used safely in pregnant or breastfeeding women.

The lowest dose possible for the shortest possible amount of time would be used. If you think you have had a side-effect to one of your medicines you can report this on the Yellow Card Scheme. You can do this online at www. The Yellow Card Scheme is used to make pharmacists, doctors and nurses aware of any new side-effects that medicines or any other healthcare products may have caused. If you wish to report a side-effect, you will need to provide basic information about:.

Indian J Endocrinol Metab. PLoS Med. I was misdiagnosed by my GP who prescribed prednisolone. I was on them for 3 years and struggled to get off them even though I tapered quite slowly. Now I am off them for a year but I am still Disclaimer: This article is for information only and should not be used for the diagnosis or treatment of medical conditions.

Egton Medical Information Systems Limited has used all reasonable care in compiling the information but make no warranty as to its accuracy. Consult a doctor or other health care professional for diagnosis and treatment of medical conditions. For details see our conditions. Topical Steroids excluding Inhaled Steroids. In this series. Steroid medicines known as corticosteroids are man-made versions of natural steroids. In this article What oral steroids are there?

Types of oral steroids What are oral steroids usually prescribed for? What is the dose? When do I take it? Do steroids cause any side-effects? Who cannot take oral corticosteroids? How do I stop oral steroids? Some other important points about oral steroids Can I take other medicines when I am taking steroids?

Confounding by indication was impossible to eliminate fully from such a study i. Get our weekly email update , and explore our library of practice updates and review articles. PulmCCM is an independent publication not affiliated with or endorsed by any organization, society or journal referenced on the website.

Terms of Use Privacy Policy. No spam. FDA approves new phrenic nerve stimulator for central sleep apnea Should patients watch videos of CPR before code status decisions? Authors concluded, These findings do not support oral steroids for treatment of acute lower respiratory tract infection in the absence of asthma. Share this: Click to share on Facebook Opens in new window Click to share on Twitter Opens in new window Click to email this to a friend Opens in new window.

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