Oral Corticosteroids for Post-infectious Cough in Adults (OSPIC)

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.

Study Overview

• Status: Terminated
• Conditions: Post-infectious Cough
• Intervention / Treatment: Drug: PREDNISON Galepharm Tabl. 20 mg; Drug: placebo tablets

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 3

Contacts and Locations

Study Locations

• Switzerland
  • Liestal, Switzerland, 4410
    • Centre for Primary Health Care (uniham-bb); University of Basel; Kantonsspital Baselland
  • Lucerne, Switzerland, 6004
    • Institute of Primary and Community Care, University of Lucerne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: PREDNISON Galepharm Tabl. 20 mg; 5 daily- doses of 40 mg (2 tablets of 20 mg) of prednisone
Placebo Comparator: 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.	Drug: placebo tablets; 5 daily- doses of placebo (2 tablets)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Overall cessation of cough	Overall cessation of cough (yes/ no)	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	within 3 months following randomisation
Total Adverse Events (number)	Total Adverse Events (number)	within 3 months after randomization
Serious Adverse Events (number)	Serious Adverse Events (number)	within 3 months after randomization

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Swiss National Science Foundation
• Investigators: Principal Investigator: Andreas Zeller, Prof. Dr. med, Centre for Primary Health Care (uniham-bb); University of Basel

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2020
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: January 14, 2020
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Upper Respiratory Tract Infection; oral corticosteroid treatment; Cough-related Quality of Life (QoL)
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Signs and Symptoms, Respiratory; Infections; Communicable Diseases; Cough
• Other Study ID Numbers: 2019-02214; ex16Zeller

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No