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
Protocol serial number	K/588
Sponsor	MKL Institute of Clinical Research (MKL Institut für Klinische Forschung GmbH) (Germany)
Funder	Cassella-med GmbH & Co. KG. (Germany)

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

Medizinische Klinik I
Klinikum Fürth
Fürth
90766
Germany

Phone	+49 (0)911 75801101
Email	med1@klinikum-fuerth.de

Study information

Primary study design	Interventional
Study design	Multicentre randomised double-blind placebo-controlled parallel-group trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Cineole
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	06/07/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

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	22/07/2009		Yes	No