Condition category
Respiratory
Date applied
05/05/2009
Date assigned
11/05/2009
Last edited
11/05/2009
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 Fuerth
Fuerth
90766
Germany
+49 (0)911 7580 1101
med1@klinikum-fuerth.de

Additional identifiers

EudraCT number

2006-001656-13

ClinicalTrials.gov number

Protocol/serial number

K/599

Study information

Scientific title

Multicentre, 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

Acronym

Study hypothesis

Concomitant therapy with cineole will improve lung function, symptoms and quality of life in patients with asthma.

Ethics approval

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

Study design

Multicentre randomised double-blind placebo-controlled parallel group comparison

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Asthma

Intervention

Cineole 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 type

Drug

Phase

Phase III

Drug names

Cineole

Primary outcome measures

Composite 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 measures

1. 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 trial start date

29/11/2006

Overall trial end date

28/01/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240 patients

Participant exclusion criteria

1. Chronic obstructive pulmonary disease (COPD)
2. Co-medication with other mucolytics
3. Infection at the beginning of the study

Recruitment start date

29/11/2006

Recruitment end date

28/01/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Medizinische Klinik I
Fuerth
90766
Germany

Sponsor information

Organisation

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

Sponsor details

Dr. Uwe Dethlefsen
Pauwelsstr. 19
Aachen
52074
Germany
+49 (0)241 963 2121
MKLKLIFO@t-onlie.de

Sponsor type

Research organisation

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

Publication citations

Additional files

Editorial Notes