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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Research Site
  Rionegro, Colombia Recruiting
• Research Site
  Alexandria, Egypt Recruiting
• Research Site
  Cairo, Egypt Recruiting
• Research Site
  Jawa Barat, Indonesia, Indonesia Recruiting
• Research Site
  Jakarta, Indonesia Recruiting
• Research Site
  Amman, Jordan Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.