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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04232449
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : December 15, 2021
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 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 : November 6, 2020
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough Steroids

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Cough-related Quality of Life (QoL) assessed by the Leicester Cough Questionnaire (LCQ) score [ Time Frame: 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 :
  1. Change in Cough-related QoL assessed by the LCQ score [ Time Frame: 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.

  2. Overall cessation of cough [ Time Frame: assessment done 7, 14, 28 days and 3 months after randomization ]
    Overall cessation of cough (yes/ no)

  3. Incidence rate of re-consultations with the treating GP and/or hospitalisations [ Time Frame: within 3 months following randomisation ]
    Incidence rate of re-consultations with the treating General Physician (GP) and/or hospitalisations

  4. Total Adverse Events (number) [ Time Frame: within 3 months after randomization ]
    Total Adverse Events (number)

  5. Serious Adverse Events (number) [ Time Frame: within 3 months after randomization ]
    Serious Adverse Events (number)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04232449


Contacts
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Contact: Andreas Zeller, Prof. Dr. med +41 (0)61 925 20 75 andreas.zeller@unibas.ch
Contact: Oana Brancati-Badarau, Dr. sc. med. +49 (0)176 23 92 89 13 oana.brancati-badarau@unibas.ch

Locations
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Switzerland
Centre for Primary Health Care (uniham-bb); University of Basel; Kantonsspital Baselland Recruiting
Liestal, Switzerland, 4410
Contact: Andreas Zeller, Prof. Dr. med    +41 (0)61 925 20 75    andreas.zeller@unibas.ch   
Contact: Oana Brancati-Badarau, Dr. sc. med.    +49 (0)176 23 92 89 13    oana.brancati-badarau@unibas.ch   
Sub-Investigator: Joerg Leuppi, Prof. Dr. med         
Institute of Primary and Community Care, University of Lucerne Recruiting
Lucerne, Switzerland, 6004
Contact: Christoph Merlo, Dr. med    +41 41 410 88 85    merlo.c@bluewin.ch   
Sub-Investigator: Stefan Essig, Dr. med         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Swiss National Science Foundation
Investigators
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Principal Investigator: Andreas Zeller, Prof. Dr. med Centre for Primary Health Care (uniham-bb); University of Basel
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT04232449    
Other Study ID Numbers: 2019-02214; ex16Zeller
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: December 15, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
Upper Respiratory Tract Infection
oral corticosteroid treatment
Cough-related Quality of Life (QoL)
Additional relevant MeSH terms:
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Communicable Diseases
Infections
Cough
Respiration Disorders
 Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Disease Attributes
Pathologic Processes