Oral Corticosteroids for Post-infectious Cough in Adults

NCT ID: NCT04232449

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-06
• Study Completion Date: 2024-04-30

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.

Conditions

Post-infectious Cough

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention group

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

Group Type: ACTIVE_COMPARATOR

PREDNISON Galepharm Tabl. 20 mg

Intervention Type: DRUG

5 daily- doses of 40 mg (2 tablets of 20 mg) of prednisone

Control group

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.

Group Type: PLACEBO_COMPARATOR

placebo tablets

Intervention Type: DRUG

5 daily- doses of placebo (2 tablets)

Interventions

PREDNISON Galepharm Tabl. 20 mg

5 daily- doses of 40 mg (2 tablets of 20 mg) of prednisone

Intervention Type: DRUG

placebo tablets

5 daily- doses of placebo (2 tablets)

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss National Science Foundation

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Zeller, Prof. Dr. med

Role: PRINCIPAL_INVESTIGATOR

Centre for Primary Health Care (uniham-bb); University of Basel

Locations

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

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 33225983 (View on PubMed)

Other Identifiers

2019-02214; ex16Zeller

Identifier Type: -

Identifier Source: org_study_id