Real-World Effectiveness of a Triple Combination BDP/FF/GB in a Single Pressurised Metered Dose Inhaler in COPD Patients (TRIPHY)

Launched by CHIESI FARMACEUTICI S.P.A. · Jun 25, 2024

Keywords

ClinConnect Summary

The TRIPHY clinical trial is studying the effectiveness of a new inhaler that combines three medications—Beclometasone Diproprionate, Formoterol Fumarate, and Glycopyrronium Bromide—into one convenient device for patients with Chronic Obstructive Pulmonary Disease (COPD). This inhaler, called Trimbow®, aims to help improve breathing and manage symptoms in everyday life. The trial is currently looking for participants aged 40 and older who have been diagnosed with COPD and have a specific level of breathing difficulty, as measured by a questionnaire.

To participate, individuals must be willing to sign a consent form and have started using the new inhaler within the last 12 weeks. However, those who have recently been hospitalized for COPD flare-ups or have participated in other clinical trials shortly before starting this study will not be eligible. Participants can expect to be monitored for about 12 weeks to see how well the inhaler works for them, and their experiences will contribute to understanding how effective this treatment is in real-world settings.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects who are willing and able to give their written consent to participate in the study
• • 2. Aged ≥40 years at BDP/FF/GB initiation
• • 3. Had documented diagnosis of COPD prior to BDP/FF/GB initiation
• • 4. Baseline CAT total score ≥10 (at the time of BDP/FF/GB initiation OR within the 12 weeks prior to treatment initiation, if no CAT total score is available on BDP/FF/GB initiation date)
• • 5. Subjects who have initiated treatment with BDP/FF/GB within 12 weeks prior to informed consent form (ICF) signature, or on date of ICF signature
• Exclusion Criteria:
• • 1. Subjects who had been admitted to hospital for a COPD exacerbation within the last 4 weeks prior to BDP/FF/GB initiation
• • 2. Subjects who are not likely to come back 12-weeks after BDP/FF/GB initiation, per Investigator judgement
• • 3. Participation in any clinical trial in the 4 weeks prior to BDP/FF/GB initiation
• • 4. Subjects had used any other single inhaler triple therapy before or at BDP/FF/GB initiation