Post-infectious CoughPhase 3OSPICNCT04232449
Oral Corticosteroids for Post-infectious Cough in Adults
A Phase 3 study testing PREDNISON Galepharm Tabl. 20 mg in people with Post-infectious Cough, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-infectious Cough
- What is being tested?
- PREDNISON Galepharm Tabl. 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 6 Nov 2020to 30 Apr 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Centre for Primary Health Care (uniham-bb); University of Basel; Kantonsspital Baselland
Liestal, 4410
Institute of Primary and Community Care, University of Lucerne
Lucerne, 6004
About this study
Official title: Oral Corticosteroids for Post-infectious Cough in Adults: A Double-blind Randomised Placebo-controlled Trial in Swiss Family Practices (OSPIC Trial)
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.
- Conditions
- Post-infectious Cough
- Being tested
- PREDNISON Galepharm Tabl. 20 mg, placebo tablets
- Keywords
- Upper Respiratory Tract Infection, oral corticosteroid treatment, Cough-related Quality of Life (QoL)
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREDNISON Galepharm Tabl. 20 mgDrug
5 daily- doses of 40 mg (2 tablets of 20 mg) of prednisone
placebo tabletsDrug
5 daily- doses of placebo (2 tablets)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: PREDNISON Galepharm Tabl. 20 mg |
| 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. Receives: Drug: placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: assessment done 14 days after randomisation
Secondary outcomes (5)
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.
Measured: assessment done at 7 and 28 days and at 3 months after randomisation
Overall cessation of cough
Overall cessation of cough (yes/ no)
Measured: 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
Measured: within 3 months following randomisation
Total Adverse Events (number)
Total Adverse Events (number)
Measured: within 3 months after randomization
Serious Adverse Events (number)
Serious Adverse Events (number)
Measured: within 3 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start6 Nov 2020
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Why it stopped: too few patients were included
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-infectious CoughStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Andreas Zeller, Prof. Dr. med, Principal investigator, Centre for Primary Health Care (uniham-bb); University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232449
- Sponsor's protocol ID
- 2019-02214; ex16Zeller
- Other IDs
- 2019
- Acronym
- OSPIC
- Status last verified
- Jul 2024
- First submitted
- 14 Jan 2020
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33225983
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Corticosteroids for Post-infectious Cough in Adults: A Double-blind Randomised Placebo-controlled Trial in Swiss Family Practices (OSPIC Trial)
- ClinicalTrials.gov ID
- NCT04232449
- Acronym / sponsor ID
- OSPIC / 2019-02214; ex16Zeller
- Conditions
- Post-infectious Cough
- Keywords
- Upper Respiratory Tract Infection, oral corticosteroid treatment, Cough-related Quality of Life (QoL)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: too few patients were included
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Drug: PREDNISON Galepharm Tabl. 20 mgIdentically 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 |
| Control group | Placebo comparator | Drug: placebo tabletsIdentically 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PREDNISON Galepharm Tabl. 20 mg5 daily- doses of 40 mg (2 tablets of 20 mg) of prednisone | Drug | Intervention group |
| placebo tablets5 daily- doses of placebo (2 tablets) | Drug | Control group |
Primary outcome
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.
5 secondary outcomes
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
Overall cessation of cough
Time frame: assessment done 7, 14, 28 days and 3 months after randomization
Incidence rate of re-consultations with the treating GP and/or hospitalisations
Time frame: within 3 months following randomisation
Total Adverse Events (number)
Time frame: within 3 months after randomization
Serious Adverse Events (number)
Time frame: within 3 months after randomization
Results and safety
The study was stopped early (reason given: too few patients were included). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 33225983Merlo 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Zeller, Prof. Dr. med principal investigator
Centre for Primary Health Care (uniham-bb); University of Basel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PREDNISON Galepharm Tabl. 20 mg in people with Post-infectious Cough, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: too few patients were included). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough-related Quality of Life (QoL) assessed by the Leicester Cough Questionnaire (LCQ) score (time frame: assessment done 14 days after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04232449, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.