Multicentre, randomised, double-blind, placebo-controlled, parallel-group comparison in order to prove efficacy and tolerability of cineole in the long-term treatment of patients with chronic obstructive pulmonary disease (COPD)
| ISRCTN | ISRCTN07600011 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07600011 |
| Secondary identifying numbers | K/588 |
- Submission date
- 15/10/2008
- Registration date
- 27/10/2008
- Last edited
- 30/07/2009
- 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 Heinrich Worth
Scientific
Scientific
Medizinische Klinik I
Klinikum Fürth
Fürth
90766
Germany
| Phone | +49 (0)911 75801101 |
|---|---|
| med1@klinikum-fuerth.de |
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) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Concomitant cineole therapy in addition to basic treatment will reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD). |
| Ethics approval(s) | 1. Ethics Committee of Bayerische Landesaerztekammer, Muenchen, approved on 11th September 2003 2. Medical Association Nordrhein, Duesseldorf, approved on 11th November 2003 3. Medical Association Westfalen-Lippen, Muenster, approved on 18th September 2003 4. Medical Association Hessen, Frankfurtf, approved on 2nd October 2003 5. Medical Association Hamburg, approved on 12th September 2003 6. Ethics Committee of Saechsiche Landesaertekammer, Dresden, approved on 15th December 2003 |
| Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease (COPD) |
| Intervention | Cineole 200 mg (oral) three times per day in addition to basic treatment, for 6 months during winter. Control group received placebo capsules. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cineole |
| Primary outcome measure | Difference between exacerbations (number, time, sevrity). The primary and secondary outcomes were assessed at initial visit and after 1, 2 ,3, 4, 5 and 6 months of treatment. |
| Secondary outcome measures | 1. Symptoms of COPD (dyspnoea, secretion, cough) 2. Spirometry: FEV1, forced vital capacity (FVC), vital capacity (VC) 3. Quality of life, assessed by the St George's Respiratory Questionnaire (SGRQ) The primary and secondary outcomes were assessed at initial visit and after 1, 2 ,3, 4, 5 and 6 months of treatment. |
| Overall study start date | 26/09/2003 |
| Completion date | 06/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 240 |
| Key inclusion criteria | 1. Patients (both males and females) with COPD, at least three exacerbations during the winter months 2. Forced expiratory volume in 1 second (FEV1) greater than 30% and less than 70% of predicted value, increase of FEV1 less than 15% and less than 200 ml after inhalation of beta-agonists 3. Smoker/ex-smoker greater than 10 pack years |
| Key exclusion criteria | 1. Aged less than 40 years and greater than 80 years 2. Asthma bronchiale 3. Comedication with other mucolytics 4. Infection at the beginning of the study |
| Date of first enrolment | 26/09/2003 |
| Date of final enrolment | 06/07/2005 |
Locations
Countries of recruitment
- Germany
Study participating centre
Medizinische Klinik I
Fürth
90766
Germany
90766
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
52074
Germany
| Phone | +49 (0)241 9632121 |
|---|---|
| MKLKLIFO@t-online.de |
Funders
Funder type
Industry
Cassella-med GmbH & Co. KG. (Germany)
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 | 22/07/2009 | Yes | No |
