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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)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN07600011
Enrollment
240
Registered
2008-10-27
Start date
2003-09-26
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease (COPD) Respiratory Other chronic obstructive pulmonary disease

Interventions

Cineole 200 mg (oral) three times per day in addition to basic treatment, for 6 months during winter. Control group received placebo capsules.

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 2, 2026