Post-infectious Cough
Conditions
Keywords
Upper Respiratory Tract Infection, oral corticosteroid treatment, Cough-related Quality of Life (QoL)
Brief summary
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.
Interventions
DRUGPREDNISON Galepharm Tabl. 20 mg
5 daily- doses of 40 mg (2 tablets of 20 mg) of prednisone
DRUGplacebo tablets
5 daily- doses of placebo (2 tablets)
Sponsors
Swiss National Science Foundation
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
blinded patients, physicians and outcome assessors
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cough-related Quality of Life (QoL) assessed by the Leicester Cough Questionnaire (LCQ) score | assessment done 14 days after randomisation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cough-related QoL assessed by the LCQ score | assessment done at 7 and 28 days and at 3 months after randomisation | 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. |
| Overall cessation of cough | assessment done 7, 14, 28 days and 3 months after randomization | Overall cessation of cough (yes/ no) |
| Incidence rate of re-consultations with the treating GP and/or hospitalisations | within 3 months following randomisation | Incidence rate of re-consultations with the treating General Physician (GP) and/or hospitalisations |
| Total Adverse Events (number) | within 3 months after randomization | Total Adverse Events (number) |
| Serious Adverse Events (number) | within 3 months after randomization | Serious Adverse Events (number) |
Countries
Switzerland
Outcome results
None listed