Efficacy and safety of cineole in patients with acute bronchitis with productive cough
| ISRCTN | ISRCTN37784439 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37784439 |
| Clinical Trials Information System (CTIS) | 2008-006061-86 |
| Protocol serial number | K/604 |
| Sponsor | MKL Institute of Clinical Research (MKL Institut für Klinische Forschung GmbH) (Germany) |
| Funder | Cassella-med GmbH (Germany) - research grant |
- Submission date
- 02/02/2010
- Registration date
- 24/02/2010
- Last edited
- 25/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Jürgen Fischer
Scientific
Scientific
Klinik Norderney
Kaiserstr. 26
Norderney
26548
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised double blind placebo controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Multicentre, randomised, double-blind, placebo-controlled parallel group comparison in order to prove efficacy and safety of Cineole in patients with acute bronchitis with productive cough |
| Study objectives | Change of bronchitis-sum-score will improve more in the cineole group |
| Ethics approval(s) | Lower Saxony (Niedersachsen) Medical Association Ethics Committee approved on the 23/12/2009 (ref: 15/2009) |
| Health condition(s) or problem(s) studied | Acute bronchitis with productive cough |
| Intervention | Patients will be randomised to receive either: 1. Cineole 2. Placebo One capsule with 200 mg or without active ingredient will be given three times daily over a period of 10 days. The capsules are organoleptically identical. The follow-up period will be four days. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cineole |
| Primary outcome measure(s) |
Bronchitis-sum-score, including the most relevant parameters: |
| Key secondary outcome measure(s) |
Single parameters of bronchitis-sum-score |
| Completion date | 30/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 240 |
| Key inclusion criteria | Patients with acute bronchitis with productive cough, a bronchitis sum-score > 7 |
| Key exclusion criteria | 1. Age < 18 and > 70 years 2. Comedication with other mucolytics |
| Date of first enrolment | 05/02/2010 |
| Date of final enrolment | 30/04/2011 |
Locations
Countries of recruitment
- Germany
Study participating centre
Klinik Norderney
Norderney
26548
Germany
26548
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 21/11/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
