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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

Tracking Information
First Submitted Date  ICMJE January 14, 2020
First Posted Date  ICMJE January 18, 2020
Last Update Posted Date December 15, 2021
Actual Study Start Date  ICMJE November 6, 2020
Estimated Primary Completion Date February 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2020)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2020)
  • 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.
  • Overall cessation of cough [ Time Frame: 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 [ Time Frame: within 3 months following randomisation ]
    Incidence rate of re-consultations with the treating General Physician (GP) and/or hospitalisations
  • Total Adverse Events (number) [ Time Frame: within 3 months after randomization ]
    Total Adverse Events (number)
  • Serious Adverse Events (number) [ Time Frame: within 3 months after randomization ]
    Serious Adverse Events (number)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Corticosteroids for Post-infectious Cough in Adults
Official Title  ICMJE Oral Corticosteroids for Post-infectious Cough in Adults: A Double-blind Randomised Placebo-controlled Trial in Swiss Family Practices (OSPIC Trial)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Post-infectious Cough
Intervention  ICMJE
  • Drug: PREDNISON Galepharm Tabl. 20 mg
    5 daily- doses of 40 mg (2 tablets of 20 mg) of prednisone
  • Drug: placebo tablets
    5 daily- doses of placebo (2 tablets)
Study Arms  ICMJE
  • 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

    Intervention: Drug: PREDNISON Galepharm Tabl. 20 mg
  • 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.

    Intervention: Drug: placebo tablets
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 14, 2020)		 204
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2024
Estimated Primary Completion Date February 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04232449
Other Study ID Numbers  ICMJE 2019-02214; ex16Zeller
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University Hospital, Basel, Switzerland
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Swiss National Science Foundation
Investigators  ICMJE
Principal Investigator: Andreas Zeller, Prof. Dr. med Centre for Primary Health Care (uniham-bb); University of Basel
PRS Account University Hospital, Basel, Switzerland
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP