The efficacy and safety of cineole during long term treatment of patients with asthma
| ISRCTN | ISRCTN90948816 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90948816 |
| Clinical Trials Information System (CTIS) | 2006-001656-13 |
| Protocol serial number | K/599 |
| Sponsor | MKL Institute of Clinical Research (MKL Institut für Klinische Forschung GmbH) (Germany) |
| Funder | Cassella-med GmbH & Co. KG (Germany) |
- Submission date
- 05/05/2009
- Registration date
- 11/05/2009
- Last edited
- 19/05/2022
- 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 Fuerth
Fuerth
90766
Germany
| Phone | +49 (0)911 7580 1101 |
|---|---|
| med1@klinikum-fuerth.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised double-blind placebo-controlled parallel group comparison |
| 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 during long term treatment of patients with asthma |
| Study objectives | Concomitant therapy with cineole will improve lung function, symptoms and quality of life in patients with asthma. |
| Ethics approval(s) | The ethics committee of the University Hospital Nuernberg-Erlangen and the ethics committees of the Medical Associations of Bayern, Hessen, Nordrhein, Westfalen and Hamburg all gave approval on the 19th October 2006 |
| Health condition(s) or problem(s) studied | Asthma |
| Intervention | Cineole was given three times daily, two capsules with 100 mg cineole each, over a period of 6 months. The capsules in the placebo group were organoleptically identical but without any active ingredient. Measurements of lung function by Spirometry, asthma symptoms and quality of life by the Asthma Questionnaire of Quality of Life (AQLQ). |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Cineole |
| Primary outcome measure(s) |
Composite scores of lung function parameters, asthma symptoms and quality of life. Assessments were initial visit and after 1, 2, 3, 4, 5 and 6 months. |
| Key secondary outcome measure(s) |
1. Lung function (spirometry) |
| Completion date | 28/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 240 |
| Key inclusion criteria | 1. Patients with asthma for at least two years 2. Reversibility of greater than 15% after inhalation of beta-agonists 3. Aged greater than or equal to 18 and less than or equal to 70 years, either sex |
| Key exclusion criteria | 1. Chronic obstructive pulmonary disease (COPD) 2. Co-medication with other mucolytics 3. Infection at the beginning of the study |
| Date of first enrolment | 29/11/2006 |
| Date of final enrolment | 28/01/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Medizinische Klinik I
Fuerth
90766
Germany
90766
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 23/05/2021 | 19/05/2022 | No | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/05/2022: EU Clinical Trials Register results added.
