Triple Therapy in Real-life: Impact on Adherence and Health Status (TRITRIAL)

Chiesi

Status: Completed

Conditions: COPD

Treatments: Drug: BDP/FF/G fixed combination

Study type: Observational

Funder types: Industry

Identifiers

NCT03963167

DFIDM-1802

Details and patient eligibility

About

The mean objectives are to evaluate the impact of BDP/FF/G fixed combination on health-status and adherence

Enrollment: 661 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Written informed consent to participate in the study;
2. Adult patients of either sex aged ≥ 40 years;
3. Patients with diagnosis of moderate to very severe COPD according to Gold Initiative for Chronic Obstructive Lung Disease (GOLD) updated 2019 (GOLD Stage 2-4);
4. COPD assessment test (CAT) score ≥ 10 at initiation of BDP/FF/G fixed combination;
5. History of >1 moderate or severe COPD exacerbation during the previous year.
6. Patients in treatment with BDP/FF/G as per local clinical practice and according to Trimbow® Summary of Product Characteristics (SmPC).

Exclusion criteria

1. According on Investigator's judgement, patients unable to comply with the requirements of the study (e.g. inability to attend all the planned study visits according to the time limits included) or patients with poorly controlled concomitant severe diseases or conditions that could interfere with the study participation;
2. Participation in an interventional clinical trial within 30 days prior to enrolment into the present study.

Trial design

661 participants in 1 patient group

Patient in treatment with BDP/FF/G fixed combination

Treatment:

Drug: BDP/FF/G fixed combination