Post-infectious Cough Clinical Trial
— OSPICOfficial title:
Oral Corticosteroids for Post-infectious Cough in Adults: A Double-blind Randomised Placebo-controlled Trial in Swiss Family Practices (OSPIC Trial)
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.
| Status | Recruiting |
| Enrollment | 204 |
| Est. completion date | February 2025 |
| Est. primary completion date | December 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Centre for Primary Health Care (uniham-bb); University of Basel; Kantonsspital Baselland | Liestal | |
| Switzerland | Institute of Primary and Community Care, University of Lucerne | Lucerne |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Basel, Switzerland | Swiss National Science Foundation |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | Overall cessation of cough | Overall cessation of cough (yes/ no) | assessment done 7, 14, 28 days and 3 months after randomization | |
| Secondary | 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 | |
| Secondary | Total Adverse Events (number) | Total Adverse Events (number) | within 3 months after randomization | |
| Secondary | Serious Adverse Events (number) | Serious Adverse Events (number) | within 3 months after randomization |