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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list