Efficacy and safety of cineole in patients with acute bronchitis with productive cough
| ISRCTN | ISRCTN37784439 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37784439 |
| EudraCT/CTIS number | 2008-006061-86 |
| Secondary identifying numbers | K/604 |
- 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
| Study design | Multicentre randomised double blind placebo controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet (in German) |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cineole |
| Primary outcome measure | Bronchitis-sum-score, including the most relevant parameters: 1. Intensity of dyspnoea 2. Sputum quantity 3. Number of daily cough attacks 4. Pain at cough 5. Auscultation 6. Spirometry Outcomes will be measured at baseline and after 4 and 10 days of treatment. |
| Secondary outcome measures | Single parameters of bronchitis-sum-score Outcomes will be measured at baseline and after 4 and 10 days of treatment. |
| Overall study start date | 05/02/2010 |
| Completion date | 30/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
Sponsor information
MKL Institute of Clinical Research (MKL Institut für Klinische Forschung GmbH) (Germany)
Industry
Industry
c/o Dr. Uwe Dethlefsen
Pauwelsstr. 19
Aachen
D 52074
Germany
Funders
Funder type
Industry
Cassella-med GmbH (Germany) - research grant
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
