Actively Recruiting
Post-marketing Phase 4 Safety & Tolerability Study of Breztri aerosphereTM in Indian Patients With Chronic Obstructive Pulmonary Disease
Led by AstraZeneca · Updated on 2026-04-20
150
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD.
CONDITIONS
Official Title
Post-marketing Phase 4 Safety & Tolerability Study of Breztri aerosphereTM in Indian Patients With Chronic Obstructive Pulmonary Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a physician-confirmed diagnosis of COPD
- History of one severe COPD exacerbation or two or more moderate exacerbations in the last 12 months
- Post-bronchodilator FEV1 between 6530% and less than 80% of predicted normal
- Male and female patients allowed
- Female participants must be of non-childbearing potential (2 years post-menopausal) or have a negative urine pregnancy test at screening
- Female participants must follow an effective contraceptive method as outlined in the protocol
- Patients must be capable of giving signed informed consent
You will not qualify if you...
- Presence of significant diseases or conditions other than COPD that may increase risk or affect study results
- Chest x-ray within 6 months before screening must be acceptable; those with clinically significant abnormalities not due to COPD are excluded
- Moderate to severe COPD exacerbations within 6 weeks before screening
- Female patients who are pregnant, lactating, or planning a family during the study
- History of hypersensitivity to the study drug or similar drugs
- Participation in any current or future interventional clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Research Site
Hyderabad, India, 500084
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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