Colobreathe
Research type
Research Study
Full title
A Cross-sectional Study to Evaluate the Effectiveness of the Colobreathe Risk Minimisation Educational Programme Among Healthcare Professionals and Patients
IRAS ID
191096
Contact name
Ian Ketchell
Contact email
Sponsor organisation
Forest Laboratories UK Limited
Duration of Study in the UK
0 years, 11 months, 15 days
Research summary
The overall objective of this survey is to evaluate the effectiveness of the Colobreathe healthcare professionals (HCP) and patient risk minimisation educational material implemented in the EU for Colobreathe.
Colobreathe®, authorized in Europe in 2012 through a centralized procedure, is indicated for the management of chronic pulmonary infections due to P. aeruginosa in patients with Cystic Fibrosis (CF) aged 6 years and older. Colobreathe® was approved by European Medicines Agency’s (EMA) 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. This survey is being conducted to address the EMA requirement to assess the effectiveness of the educational material among HCPs who prescribe or administer, and patients who use, Colobreathe® in Europe.
The survey will be conducted in Austria, Denmark France, Germany, the Netherlands, and UK among HCPs who have prescribed or administered Colobreathe® at least once in the previous 12 months prior to taking the survey, and among patients (or patients’ caregivers for patients who are either too young or too ill to take the survey by themselves) who have received Colobreathe® within 6 months prior to taking the survey. The target number of completed surveys to obtain from HCPs is 100, and from patients/caregivers combined is 200.
The survey will be fielded for 6 months. Depending on response rates, follow-up reminders will be sent to non-respondents to achieve the target sample size.
The survey is expected to start on the 01st November 2015 with the end of data collection planned in October 2016.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
16/WM/0040
Date of REC Opinion
25 Feb 2016
REC opinion
Further Information Favourable Opinion