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

Primary Purpose

Post-infectious Cough

Status
Recruiting
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
PREDNISON Galepharm Tabl. 20 mg
placebo tablets
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-infectious Cough focused on measuring Upper Respiratory Tract Infection, oral corticosteroid treatment, Cough-related Quality of Life (QoL)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Centre for Primary Health Care (uniham-bb); University of Basel; Kantonsspital BasellandRecruiting
  • Institute of Primary and Community Care, University of LucerneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention group

Control group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Overall cessation of cough
Overall cessation of cough (yes/ no)
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
Total Adverse Events (number)
Total Adverse Events (number)
Serious Adverse Events (number)
Serious Adverse Events (number)

Full Information

First Posted
January 14, 2020
Last Updated
December 14, 2021
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Swiss National Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04232449
Brief Title
Oral Corticosteroids for Post-infectious Cough in Adults
Acronym
OSPIC
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 6, 2020 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Swiss National Science Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-infectious Cough
Keywords
Upper Respiratory Tract Infection, oral corticosteroid treatment, Cough-related Quality of Life (QoL)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
blinded patients, physicians and outcome assessors
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
PREDNISON Galepharm Tabl. 20 mg
Intervention Description
5 daily- doses of 40 mg (2 tablets of 20 mg) of prednisone
Intervention Type
Drug
Intervention Name(s)
placebo tablets
Intervention Description
5 daily- doses of placebo (2 tablets)
Primary Outcome Measure Information:
Title
Cough-related Quality of Life (QoL) assessed by the Leicester Cough Questionnaire (LCQ) score
Description
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
Secondary Outcome Measure Information:
Title
Change in Cough-related QoL assessed by the LCQ score
Description
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
Title
Overall cessation of cough
Description
Overall cessation of cough (yes/ no)
Time Frame
assessment done 7, 14, 28 days and 3 months after randomization
Title
Incidence rate of re-consultations with the treating GP and/or hospitalisations
Description
Incidence rate of re-consultations with the treating General Physician (GP) and/or hospitalisations
Time Frame
within 3 months following randomisation
Title
Total Adverse Events (number)
Description
Total Adverse Events (number)
Time Frame
within 3 months after randomization
Title
Serious Adverse Events (number)
Description
Serious Adverse Events (number)
Time Frame
within 3 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Zeller, Prof. Dr. med
Phone
+41 (0)61 925 20 75
Email
andreas.zeller@unibas.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Oana Brancati-Badarau, Dr. sc. med.
Phone
+49 (0)176 23 92 89 13
Email
oana.brancati-badarau@unibas.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Zeller, Prof. Dr. med
Organizational Affiliation
Centre for Primary Health Care (uniham-bb); University of Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Primary Health Care (uniham-bb); University of Basel; Kantonsspital Baselland
City
Liestal
ZIP/Postal Code
4410
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Zeller, Prof. Dr. med
Phone
+41 (0)61 925 20 75
Email
andreas.zeller@unibas.ch
First Name & Middle Initial & Last Name & Degree
Oana Brancati-Badarau, Dr. sc. med.
Phone
+49 (0)176 23 92 89 13
Email
oana.brancati-badarau@unibas.ch
First Name & Middle Initial & Last Name & Degree
Joerg Leuppi, Prof. Dr. med
Facility Name
Institute of Primary and Community Care, University of Lucerne
City
Lucerne
ZIP/Postal Code
6004
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Merlo, Dr. med
Phone
+41 41 410 88 85
Email
merlo.c@bluewin.ch
First Name & Middle Initial & Last Name & Degree
Stefan Essig, Dr. med

12. IPD Sharing Statement

Citations:
PubMed Identifier
33225983
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.
Results Reference
derived

Learn more about this trial

Oral Corticosteroids for Post-infectious Cough in Adults

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