OSPIC: Oral Corticosteroids for Post-infectious Cough in Adults

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Recruiting

CT.gov ID

NCT04232449

Collaborator

Swiss National Science Foundation (Other)

204

Enrollment

Locations

Arms

38.8

Anticipated Duration (Months)

102

Patients Per Site

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-infectious Cough	Drug: PREDNISON Galepharm Tabl. 20 mg Drug: placebo tablets	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

204 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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 settingmulti-centre, 1:1 randomised, parallel-group, placebo-controlled, superiority trial with blinded patients, physicians and outcome assessors in a primary health care setting

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

blinded patients, physicians and outcome assessors

Primary Purpose:

Treatment

Official Title:

Oral Corticosteroids for Post-infectious Cough in Adults: A Double-blind Randomised Placebo-controlled Trial in Swiss Family Practices (OSPIC Trial)

Actual Study Start Date :

Nov 6, 2020

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Primary Health Care (uniham-bb); University of Basel; Kantonsspital Baselland	Liestal		Switzerland	4410
2	Institute of Primary and Community Care, University of Lucerne	Lucerne		Switzerland	6004