The efficacy and safety of cineole during long term treatment of patients with asthma

ISRCTN ISRCTN90948816
DOI https://doi.org/10.1186/ISRCTN90948816
EudraCT/CTIS number 2006-001656-13
Secondary identifying numbers K/599
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

Medizinische Klinik I
Klinikum Fuerth
Fuerth
90766
Germany

Phone +49 (0)911 7580 1101
Email med1@klinikum-fuerth.de

Study information

Study designMulticentre randomised double-blind placebo-controlled parallel group comparison
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleMulticentre, 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 objectivesConcomitant 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) studiedAsthma
InterventionCineole 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 typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Cineole
Primary outcome measureComposite 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.
Secondary outcome measures1. Lung function (spirometry)
2. Asthma symptoms (dyspnoea, secretion, cough)
3. Quality of life (Asthma Questionnaire of Quality of Life [AQLQ])

Assessments were initial visit and after 1, 2, 3, 4, 5 and 6 months.
Overall study start date29/11/2006
Completion date28/01/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants240 patients
Key inclusion criteria1. 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 criteria1. Chronic obstructive pulmonary disease (COPD)
2. Co-medication with other mucolytics
3. Infection at the beginning of the study
Date of first enrolment29/11/2006
Date of final enrolment28/01/2009

Locations

Countries of recruitment

  • Germany

Study participating centre

Medizinische Klinik I
Fuerth
90766
Germany

Sponsor information

MKL Institute of Clinical Research (MKL Institut für Klinische Forschung GmbH) (Germany)
Research organisation

Dr. Uwe Dethlefsen
Pauwelsstr. 19
Aachen
52074
Germany

Phone +49 (0)241 963 2121
Email MKLKLIFO@t-onlie.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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot 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

Editorial Notes

19/05/2022: EU Clinical Trials Register results added.