Breztri Aerosphere safety and tolerability in Indian patients with moderate to severe COPD

Post-marketing Phase IV, Multicenter, Prospective Study to Observe the Safety and Tolerability of Breztri aerosphereTM Containing a Fixed Dose Combination of Budesonide 160 mcg/ Glycopyrronium 7.2 mcg/ Formoterol Fumarate Dehydrate 5 mcg in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

This trial will test whether taking Breztri Aerosphere as a daily maintenance inhaler is safe and well tolerated in Indian adults with moderate to severe COPD.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Locations: 1 site (Hyderabad)
• Trial ID: NCT06531798 on ClinicalTrials.gov

What this trial studies

This is a post-marketing, single-arm Phase 4 interventional study sponsored by AstraZeneca that follows Indian patients with moderate to severe COPD for 26 weeks, including 24 weeks of treatment with Breztri Aerosphere. The study enrolls patients with a history of one severe or two or more moderate COPD exacerbations in the prior 12 months and a post-bronchodilator FEV1 between 30% and <80% of predicted. Female participants must be non-childbearing or use effective contraception and have a negative pregnancy test at screening. Safety and tolerability data including adverse events, vital signs, and treatment‑related issues will be collected at scheduled visits at the Hyderabad research site.

Who should consider this trial

Good fit: Adults in India with physician-confirmed moderate to severe COPD who had at least one severe or two moderate exacerbations in the past 12 months, with post-bronchodilator FEV1 between 30% and <80% predicted, who can give informed consent and meet pregnancy/contraception requirements.

Not a fit: Patients with significant comorbid conditions that could affect safety or study participation, those with FEV1 outside the 30–<80% range, pregnant women, or those unable to attend the Hyderabad site are unlikely to benefit from participating.

Why it matters

Potential benefit: If results show good safety and tolerability, patients and clinicians in India could have greater confidence using Breztri Aerosphere as a maintenance therapy for moderate to severe COPD.

How similar studies have performed: Global trials of Breztri Aerosphere and other triple‑therapy inhalers have shown efficacy and an acceptable safety profile, but post‑marketing safety data specifically in Indian patients are limited.

Eligibility criteria

Inclusion Criteria:

Patients with a physician-confirmed diagnosis of COPD

* With a history of one severe COPD exacerbation or two or more moderate COPD exacerbations in the preceding 12 months.
* Post-bronchodilator FEV1 should be between ≥30 % to \<80% of the predicted normal.
* Both male and female patients are allowed in the study
* Female of Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal)
* A urine pregnancy test must be negative at screening.
* female participant must follow effective contraceptive method as outlined in protocol
* Patients should be capable of giving signed informed consent

Exclusion Criteria:

* Significant diseases or conditions other than COPD, which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
* Chest x-ray within 6 months before screening must be acceptable to the investigator. Subjects who have a chest x-ray that reveals clinically significant abnormalities not believed to be due to the presence of COPD should not be included. A chest x-ray must be conducted if the most recent chest x-ray is not available at the time of screening.
* Patients having moderate to severe exacerbations within 6 weeks before the Screening period.
* Female patients who are pregnant or lactating or planning a family during the study period.
* Patients with either a history of hypersensitivity to excipients of the study drug or drugs with a similar chemical structure or class to the study drug.
* Patients participating in any current or future interventional trial during the study will not be enrolled in the current study.

Where this trial is running

Hyderabad

• Research Site — Hyderabad, India (Recruiting)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Moderate to Severe COPD