Condition category
Respiratory
Date applied
02/02/2010
Date assigned
24/02/2010
Last edited
25/11/2013
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 Jürgen Fischer

ORCID ID

Contact details

Klinik Norderney
Kaiserstr. 26
Norderney
26548
Germany

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

Sponsor information

Organisation

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

Sponsor details

c/o Dr. Uwe Dethlefsen
Pauwelsstr. 19
Aachen
D 52074
Germany

Sponsor type

Industry

Website

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

  1. 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.

Additional files

Editorial Notes