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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
5 daily- doses of 40 mg (2 tablets of 20 mg) of prednisone
5 daily- doses of placebo (2 tablets)
Centre for Primary Health Care (uniham-bb); University of Basel; Kantonsspital Baselland
Liestal, Switzerland
Institute of Primary and Community Care, University of Lucerne
Lucerne, Switzerland
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.
Time frame: assessment done 14 days after randomisation
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.
Time frame: assessment done at 7 and 28 days and at 3 months after randomisation
Overall cessation of cough
Overall cessation of cough (yes/ no)
Time frame: 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
Time frame: within 3 months following randomisation
Total Adverse Events (number)
Total Adverse Events (number)
Time frame: within 3 months after randomization
Serious Adverse Events (number)
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Serious Adverse Events (number)
Time frame: within 3 months after randomization