Study identification

EU PAS number

EUPAS12030

Study ID

34147

Official title and acronym

A Cross-sectional Study to Evaluate the Effectiveness of the Colobreathe Risk Minimisation Educational Programme Among Healthcare Professionals and Patients

DARWIN EU® study

No

Study countries

Austria
Denmark
France
Germany
Netherlands
United Kingdom

Study description

Colobreathe, authorised in Europe in 2012 through a centralized procedure, is indicated for the management of chronic pulmonary infections due to P. aeruginosa in patients with CF aged 6 years and older. Colobreathe was approved with a requirement for additional risk minimisation measures, specifically, that healthcare professionals (HCPs) and patients are provided with educational material containing information on the need to comply with treatment, instructions on how to use the product (capsules and Turbospin inhaler device), and information on side effects. Educational material has been developed and disseminated in Europe to inform HCPs and patients of important information on the safe use of Colobreathe. This study is being conducted to assess the effectiveness of the educational material among HCPs who prescribe or administer, and patients who use, Colobreathe in Europe. The proposed study utilises a cross-sectional survey study design.

Study status

Finalised
Research institutions and networks

Institutions

Teva B.V.

Contact details

Terri Madison

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Forest Laboratories UK Limited, Teva B.V.
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)