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ISRCTN
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ISRCTN37784439
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ClinicalTrials.gov identifier
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Public title
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Efficacy and safety of cineole in patients with acute bronchitis with productive cough
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Scientific title
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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
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Acronym
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NA
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Serial number at source
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K/604
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Study hypothesis
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Change of bronchitis-sum-score will improve more in the cineole group
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Lay summary
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Not provided at time of registration
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Ethics approval
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Lower Saxony (Niedersachsen) Medical Association Ethics Committee approved on the 23rd of December 2009 (ref: 15/2009)
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Study design
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Multicentre randomised double blind placebo controlled parallel group trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Acute bronchitis with productive cough
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Participants - inclusion criteria
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Patients with acute bronchitis with productive cough, a bronchitis sum-score > 7
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Participants - exclusion criteria
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1. Age < 18 and > 70 years
2. Comedication with other mucolytics
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Anticipated start date
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05/02/2010
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Anticipated end date
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30/04/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet (in German)
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Target number of participants
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240
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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Single parameters of bronchitis-sum-score
Outcomes will be measured at baseline and after 4 and 10 days of treatment.
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Sources of funding
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Cassella-med GmbH (Germany) - research grant
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Trial website
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Publications
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Contact name
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Prof
Jürgen
Fischer
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Address
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Klinik Norderney
Kaiserstr. 26
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City/town
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Norderney
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Zip/Postcode
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26548
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Country
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Germany
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Sponsor
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MKL Institute of Clinical Research (MKL Institut für Klinische Forschung GmbH) (Germany)
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Address
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c/o Dr. Uwe Dethlefsen
Pauwelsstr. 19
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City/town
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Aachen
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Zip/Postcode
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D 52074
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Country
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Germany
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Date applied
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02/02/2010
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Last edited
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04/10/2011
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Date ISRCTN assigned
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24/02/2010
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