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One-year real-world outcomes with Breztri/Trixeo (BGF) in adults with moderate to severe COPD

Real-world, International, Multicentre, Non-interventional, Prospective Cohort to Assess Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri/Trixeo in Routine Care Settings

Observational AstraZeneca · NCT07069829

See how adults with moderate to severe COPD do over 12 months after starting Breztri/Trixeo (BGF) in routine care settings.

Quick facts

Study typeObservational
Enrollment1400 (estimated)
Ages30 Years to 80 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Locations21 sites (Alexandria and 20 other locations)
Trial IDNCT07069829 on ClinicalTrials.gov

What this trial studies

This international, multicenter observational study follows adults with moderate to severe COPD who are prescribed triple inhaled therapy (BGF) to track clinical and patient-reported outcomes over 12 months in routine clinical care. Data collected include exacerbation frequency, lung function measures, symptoms, quality of life, and healthcare use as documented by treating physicians and patient questionnaires. Patients are enrolled only if BGF was prescribed prior to consent and treatment is initiated as part of usual care, with no experimental intervention or mandated treatment changes. The aim is to generate real-world evidence across diverse healthcare settings in Latin America, Asia, and Africa to complement findings from randomized trials.

Who should consider this trial

Good fit: Adults aged 30–79 with a physician-diagnosed COPD of at least 12 months who have been prescribed BGF but have not yet started it and who can complete study questionnaires are ideal candidates.

Not a fit: Patients who already started BGF before giving consent, who cannot read or complete the required questionnaires, or whose respiratory condition is not COPD are unlikely to gain benefit from participating.

Why it matters

Potential benefit: If successful, this could show whether BGF improves everyday symptoms, reduces exacerbations, and enhances quality of life for patients outside controlled trials.

How similar studies have performed: Triple inhaled therapy (ICS+LABA+LAMA) like BGF has shown benefit in randomized controlled trials, but real-world evidence on everyday patient outcomes is still limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

The study will include patients who were prescribed BGF, but not yet initiated, according to the label (SmPC) and local market reimbursement criteria. Patients will only be included in the study if they meet the following inclusion criteria:

1. Patients diagnosed with COPD, at least 12 months before baseline, as assessed per physician's routine practice or as documented in the patient's chart.
2. Male or female patients aged over 30 years and under 80 years at the time of enrolment.
3. Patients providing a written Informed Consent\* prior to inclusion to the study.

   \*Prescription of BGF should be prior to the signed informed consent and the decision to prescribe this therapy is clearly separated from the physician's decision to include the patient in the current study.
4. Patients able and willing to read and to comprehend written instructions, and to comprehend and complete the questionnaires required by the protocol.

Exclusion Criteria:

Patients who meet any of the following criteria will not be eligible to participate in the study:

1. Patients with COPD due to documented α-1 antitrypsin deficiency.
2. Patients with recent (≤3 months) major cardiac or pulmonary events that required hospitalization (e.g., myocardial infarction, pulmonary embolism).
3. Patients previously treated with triple fixed-dose combination therapies 12 months before the screening visit or treated with Multiple Inhaled Triple Therapy (MITT) within the last 3 months before the screening visit.
4. Patients hospitalized due to COPD exacerbations within the last 30 days prior to enrolment.
5. Currently pregnant (or intending to become pregnant), breastfeeding, or lactating women.
6. Patients with a current diagnosis of asthma, active tuberculosis, lung cancer or lung metastasis, significant bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases, or other active clinically significant pulmonary diseases.
7. Patients currently participating in a non-interventional observational trial that might, in the investigator's opinion, influence the assessment for the current study or participation in any interventional trial in the last 30 days prior to enrolment.
8. Patients with respiratory tract infection (including COVID-19 infection) ) that has not resolved ≤30 days prior to BGF MDI initiation and those exhibiting persistent long-COVID symptoms are excluded from the study.

Where this trial is running

Alexandria and 20 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 DiseaseCOPDModerate to Severe Chronic Obstructive Pulmonary DiseaseSevere ExacerbationsBGF - Budesonide/Glycopyrrolate/Formoterol Fumarate
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.