Contact information
Type
Scientific
Primary contact
Prof Heinrich Worth
ORCID ID
Contact details
Medizinische Klinik I
Klinikum Fürth
Fürth
90766
Germany
+49 (0)911 75801101
med1@klinikum-fuerth.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
K/588
Study information
Scientific title
Acronym
Study hypothesis
Concomitant cineole therapy in addition to basic treatment will reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD).
Ethics approval
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
Study design
Multicentre randomised double-blind placebo-controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Cineole
Primary outcome measures
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 trial start date
26/09/2003
Overall trial end date
06/07/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
240
Participant 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
Recruitment start date
26/09/2003
Recruitment end date
06/07/2005
Locations
Countries of recruitment
Germany
Trial participating centre
Medizinische Klinik I
Fürth
90766
Germany
Sponsor information
Organisation
MKL Institute of Clinical Research (MKL Institut für Klinische Forschung GmbH) (Germany)
Sponsor details
c/o Dr Uwe Dethlefsen
Pauwelsstr. 19
Aachen
52074
Germany
+49 (0)241 9632121
MKLKLIFO@t-online.de
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Cassella-med GmbH & Co. KG. (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19624838
Publication citations
-
Results
Worth H, Schacher C, Dethlefsen U, Concomitant therapy with Cineole (Eucalyptole) reduces exacerbations in COPD: a placebo-controlled double-blind trial., Respir. Res., 2009, 10, 69, doi: 10.1186/1465-9921-10-69.