Additional identifiers
EudraCT number
2008-006061-86
ClinicalTrials.gov number
Protocol/serial number
K/604
Study information
Scientific title
Multicentre, randomised, double-blind, placebo-controlled parallel group comparison in order to prove efficacy and safety of Cineole in patients with acute bronchitis with productive cough
Acronym
Study hypothesis
Change of bronchitis-sum-score will improve more in the cineole group
Ethics approval
Lower Saxony (Niedersachsen) Medical Association Ethics Committee approved on the 23/12/2009 (ref: 15/2009)
Study design
Multicentre randomised double blind placebo controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet (in German)
Condition
Acute bronchitis with productive cough
Intervention
Patients will be randomised to receive either:
1. Cineole
2. Placebo
One capsule with 200 mg or without active ingredient will be given three times daily over a period of 10 days. The capsules are organoleptically identical.
The follow-up period will be four days.
Intervention type
Drug
Phase
Not Specified
Drug names
Cineole
Primary outcome measures
Bronchitis-sum-score, including the most relevant parameters:
1. Intensity of dyspnoea
2. Sputum quantity
3. Number of daily cough attacks
4. Pain at cough
5. Auscultation
6. Spirometry
Outcomes will be measured at baseline and after 4 and 10 days of treatment.
Secondary outcome measures
Single parameters of bronchitis-sum-score
Outcomes will be measured at baseline and after 4 and 10 days of treatment.
Overall trial start date
05/02/2010
Overall trial end date
30/04/2011
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with acute bronchitis with productive cough, a bronchitis sum-score > 7
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
240
Participant exclusion criteria
1. Age < 18 and > 70 years
2. Comedication with other mucolytics
Recruitment start date
05/02/2010
Recruitment end date
30/04/2011
Locations
Countries of recruitment
Germany
Trial participating centre
Klinik Norderney
Norderney
26548
Germany
Funders
Funder type
Industry
Funder name
Cassella-med GmbH (Germany) - research grant
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
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24261680
Publication citations
-
Results
Fischer J, Dethlefsen U, Efficacy of cineole in patients suffering from acute bronchitis: a placebo-controlled double-blind trial., Cough, 2013, 9, 1, 25, doi: 10.1186/1745-9974-9-25.