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too few patients were included
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| Name | Class |
|---|---|
| Swiss National Science Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Active Comparator | 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 |
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| Control group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PREDNISON Galepharm Tabl. 20 mg | Drug | 5 daily- doses of 40 mg (2 tablets of 20 mg) of prednisone |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Zeller, Prof. Dr. med | Centre for Primary Health Care (uniham-bb); University of Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Primary Health Care (uniham-bb); University of Basel; Kantonsspital Baselland | Liestal | 4410 | Switzerland | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33225983 | Derived | 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. |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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multi-centre, 1:1 randomised, parallel-group, placebo-controlled, superiority trial with blinded patients, physicians and outcome assessors in a primary health care setting
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blinded patients, physicians and outcome assessors
| placebo tablets | Drug | 5 daily- doses of placebo (2 tablets) |
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| 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 |
| Institute of Primary and Community Care, University of Lucerne |
| Lucerne |
| 6004 |
| Switzerland |