Clinical trial NCT04232449: Oral Corticosteroids for Post-infectious Cough in Adults
Official title: Oral Corticosteroids for Post-infectious Cough in Adults: A Double-blind Randomised Placebo-controlled Trial in Swiss Family Practices (OSPIC Trial)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Post-infectious Cough
Keywords: Upper Respiratory Tract Infection
oral corticosteroid treatment
Cough-related Quality of Life (QoL)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2020-01-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Cough-related Quality of Life (QoL) assessed by the Leicester Cough Questionnaire (LCQ) score
timeFrame: assessment done 14 days after randomisation
Secondary outcomes:
measure: Change in Cough-related QoL assessed by the LCQ score
timeFrame: assessment done at 7 and 28 days and at 3 months after randomisation
measure: Overall cessation of cough
timeFrame: assessment done 7, 14, 28 days and 3 months after randomization
measure: Incidence rate of re-consultations with the treating GP and/or hospitalisations
timeFrame: within 3 months following randomisation
measure: Total Adverse Events (number)
timeFrame: within 3 months after randomization
measure: Serious Adverse Events (number)
timeFrame: within 3 months after randomization
Other outcomes:
Locations:
city: Liestal
country: Switzerland
facility: Centre for Primary Health Care (uniham-bb); University of Basel; Kantonsspital Baselland
city: Lucerne
country: Switzerland
facility: Institute of Primary and Community Care, University of Lucerne
Study officials:
affiliation: Centre for Primary Health Care (uniham-bb); University of Basel
name: Andreas Zeller, Prof. Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Merlo C, Essig S, Brancati-Badarau DO, Leuppi JD, Speich B, Erlanger TE, Hemkens LG, Zeller A. Oral corticosteroids for post-infectious cough in adults: study protocol for a double-blind randomized placebo-controlled trial in Swiss family practices (OSPIC trial). Trials. 2020 Nov 23;21(1):949. doi: 10.1186/s13063-020-04848-4.