Oral Corticosteroids for Post-infectious Cough in Adults

Study Overview
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Brief Summary
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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.

Official Title
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Oral Corticosteroids for Post-infectious Cough in Adults: A Double-blind Randomised Placebo-controlled Trial in Swiss Family Practices (OSPIC Trial)

Conditions
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Post-infectious Cough

Intervention / Treatment
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* Drug: PREDNISON Galepharm Tabl. 20 mg
* Drug: placebo tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients seeing a GP for a dry or productive post-infectious cough (3 to 8 weeks) after Upper Respiratory Tract Infection (URTI) Patients able and willing to give informed consent by themselves and to fill in the LCQ on day 0 with the GP and to answer phone calls from the research staff/study nurse at day 7, 14, and 28, and at 3 months for outcome assessment Exclusion Criteria: Patients with known or suspected diagnoses associated with cough, such as: pneumonia or suggestive symptoms and signs (abnormal vital signs, i.e. heart rate >100/min, respiratory rate >25/min, fever), allergic rhinitis, sinusitis, bronchial asthma, chronic pulmonary disease (COPD), or gastroesophageal reflux disease, Patients with other chronic disease such as bronchiectasis, cystic fibrosis, cancer, tuberculosis, heart failure. Use of inhaled or oral corticosteroids within the last four weeks Immunodeficiency/immunocompromised state (e.g. cancer chemotherapy, HIV infection, administration of immune-suppressive agents) Pregnancy/ breastfeeding Regular treatment known to be associated with cough (e.g. angiotensin converting enzyme inhibitors) Patients with pharmacotherapy for glaucoma or osteoporosis Experienced fractures due to osteoporosis Patients with uncontrolled diabetes (as deemed by GPs who appraise whether the potential side effects of short-time corticosteroids on glucose levels exceed the hypothesised benefit on cough)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: multi-centre, 1:1 randomised, parallel-group, placebo-controlled, superiority trial with blinded patients, physicians and outcome assessors in a primary health care setting
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>Identically looking, numbered and marked medication glass jars with 5 daily doses of 40 mg (2 tablets of 20 mg) of prednisone (intervention group) are provided by General Physicians (GPs) to participants. PREDNISON Galepharm Tabl. 20 mg are manufactured according to Good Manufacturing Practice (GMP)-guidelines. The prednisone medication is manufactured by Galepharm AG, 8700 Küsnacht (ZH) and packaged and labelled by the Hospital Pharmacy of the University Hospital Basel. The PREDNISON tablets' active substance is Prednisonum; the tablets also contain Excipiens pro compresso. Swissmedic authorization 50821 | Drug: PREDNISON Galepharm Tabl. 20 mg<br>* 5 daily- doses of 40 mg (2 tablets of 20 mg) of prednisone<br>|
| Placebo Comparator: Control group<br>Identically looking, numbered and marked medication glass jars with 5 daily doses of placebo (control group) are provided by General Physicians (GPs) to participants. The content of the placebo tablets is as follows: Lactose monohydrate 140 mg, microcrystalline cellulose 68 mg, Croscarmellose sodium 5 mg, Magnesium stearate 2mg. The placebo tablets were manufactured by Apotheke Hotz, Zürichstrasse 176, CH- 8700 Küsnacht. | Drug: placebo tablets<br>* 5 daily- doses of placebo (2 tablets)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cough-related Quality of Life (QoL) assessed by the Leicester Cough Questionnaire (LCQ) score | The LCQ comprises 19 items and takes 5 to 10 minutes to complete. 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. | assessment done 14 days after randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cough-related QoL assessed by the LCQ score | The LCQ comprises 19 items and takes 5 to 10 minutes to complete. 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. | assessment done at 7 and 28 days and at 3 months after randomisation | 
| Overall cessation of cough | Overall cessation of cough (yes/ no) | assessment done 7, 14, 28 days and 3 months after randomization | 
| Incidence rate of re-consultations with the treating GP and/or hospitalisations | Incidence rate of re-consultations with the treating General Physician (GP) and/or hospitalisations | within 3 months following randomisation | 
| Total Adverse Events (number) | Total Adverse Events (number) | within 3 months after randomization | 
| Serious Adverse Events (number) | Serious Adverse Events (number) | within 3 months after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Upper Respiratory Tract Infection, oral corticosteroid treatment, Cough-related Quality of Life (QoL)