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Clinical Trials in India / NCT06531798
Recruiting Phase 4

Post-marketing Phase 4 Safety & Tolerability Study of Breztri aerosphereTM in Indian Patients With Chronic Obstructive Pulmonary Disease

NCT06531798 · tracked via the Priya Life Science India tracker
Sponsor
AstraZeneca
Phase
Phase 4
Started
2026-01-30
Last updated
2026-08-20

Condition(s) studied

Moderate to Severe COPD

Investigational drug(s) / intervention(s)

Breztri Aerosphere

Breztri Aerosphere: Budesonide 160 mcg/Glycopyrrolate 7.2 mcg/Formoterol fumarate dehydrate 5 mcg

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Research Site Dalgate, Drugjan India Recruiting
Research Site Hyderabad India Recruiting
Research Site Lucknow India Recruiting
Research Site Nagpur India Recruiting
Research Site New Delhi India Recruiting

More AstraZeneca trials in India

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06531798 on ClinicalTrials.gov ↗ ← All trials in India