Condition category
Respiratory
Date applied
15/10/2008
Date assigned
27/10/2008
Last edited
30/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes