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Evaluating the effectiveness of a new inhaler for COPD patients

A 12-Week Single-Cohort Study, to Evaluate Real-World Effectiveness of a Triple Combination Beclometasone Diproprionate/Formoterol Fumarate/Glycopyrronium Bromide (BDP/FF/GB) in a Single Pressurised Metered Dose Inhaler (Trimbow® pMDI) in Subjects With COPD

Observational Chiesi Farmaceutici S.p.A. · NCT06480890

This study is testing a new inhaler for people with COPD to see how well it works in everyday life over 12 weeks.

Quick facts

Study typeObservational
Enrollment359 (estimated)
Ages40 Years and up
SexAll
SponsorChiesi Farmaceutici S.p.A. Industry-sponsored
Locations22 sites (Beijing, Beijing and 21 other locations)
Trial IDNCT06480890 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the real-world effectiveness of a triple combination inhaler containing Beclometasone Diproprionate, Formoterol Fumarate, and Glycopyrronium Bromide in patients with Chronic Obstructive Pulmonary Disease (COPD) in China. It involves a multi-centre, single-cohort design with both retrospective and prospective data collection over a 12-week period. Participants will be monitored from the initiation of treatment, with data collected on their lung function and overall health status. The study seeks to provide insights into the inhaler's effectiveness in a real-world setting.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 and older with a documented diagnosis of COPD and a baseline CAT total score of 10 or higher.

Not a fit: Patients who have experienced a COPD exacerbation requiring hospitalization in the last 4 weeks or those who have previously used other single inhaler triple therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management of COPD symptoms and better quality of life for patients.

How similar studies have performed: Other studies have shown positive outcomes with similar inhaler combinations, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Beijing, Beijing and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Obstructive Pulmonary DiseaseLung functionsCOPD
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.