Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)

Data collection methods

Primary data collection
Non-interventional study

Non-interventional study design

Cross-sectional
Study drug and medical condition

Name of medicine

COLOBREATHE
Population studied

Short description of the study population

Healthcare professionals (HCPs) who have prescribed or administered Colobreathe within the 12 months prior to completing the survey, and patients (or their caregivers) who have received Colobreathe within the 6 months prior to completing the survey.

Age groups

Children (2 to < 12 years)
Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

300
Study design details

Main study objective

The overall objective of this study is to evaluate process indicators of the effectiveness of the risk minimisation educational material implemented in the EU for Colobreathe, specifically, knowledge rates, and measures of distribution and use of, the Colobreathe RMM educational material.

Outcomes

Knowledge rates of information included in the Colobreathe RMM educational material. Measures of distribution and use of the Colobreathe RMM educational material.

Data analysis plan

The primary analysis population will include all HCPs and patients/caregivers who have completed the survey. The primary criteria are the respondents’ knowledge rates across each of the key risk minimisation educational messages for Colobreathe. Other criteria are measures of distribution and use of educational material.Knowledge rates for each of the key risk minimisation educational messages for Colobreathe will be calculated with 95% two-sided CI. Knowledge rates may also be reported by relevant subgroups such as country and recruitment method.