Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT06511193
Eligibility Criteria:
Inclusion Criteria:
* Physician diagnosis of COPD
* COPD patients in the Best Care Network who have a CAT score \>=10
* Age \>=35 at time of enrolment
* Minimum 12-month recorded prior medical history for patients
* Physician decision and patient agreement to initiate treatment with Breztri based on routine care (and in accordance with label and reimbursement criteria)
* Ability to read English and to provide consent to inclusion in the study
Exclusion Criteria:
* Diagnosis of asthma
* Dementia or other health issues related to memory
* Inability to use inhalers
* COPD due to documented α-1 antitrypsin deficiency
* Previous treatment with triple fixed-dose combination therapy in 12 months prior to screening visit
* Hospitalisation due to COPD exacerbation within the last 30 days prior to enrolment
* Pregnancy or lactation period
* Participation in an ongoing clinical interventional or observational trial for another COPD medication (or completed another trial within last 30 days of initiating BGF)
* Patient self-reporting or a physician record with an active COVID-19 infection at time of enrolment or hospitalized due to COVID-19 infection in the last 60 days
* Previous enrolment in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
130 Years
Study:
NCT06511193
Study Brief:
Protocol Section:
NCT06511193