RecruitingPhase 4NCT06531798

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

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


Sponsor

AstraZeneca

Enrollment

150 participants

Start Date

Dec 19, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at the safety and tolerability of a three-in-one inhaler called Breztri Aerosphere (which combines budesonide, glycopyrrolate, and formoterol) in Indian patients with chronic obstructive pulmonary disease (COPD) — a long-term lung condition that makes it hard to breathe. This is a post-marketing study, meaning the drug is already approved and researchers want to gather real-world safety data in India. **You may be eligible if...** - You have a confirmed diagnosis of COPD from a doctor - You have had at least one severe COPD flare-up or two moderate ones in the past year - Your lung function test (FEV1) is between 30% and 80% of expected - You are male or female and not pregnant or breastfeeding - You are post-menopausal or using effective contraception **You may NOT be eligible if...** - You have had a moderate or severe COPD flare-up in the last 6 weeks - You are pregnant, breastfeeding, or planning to become pregnant - You have had an allergic reaction to similar medications - You are currently in another interventional clinical trial - You have serious other health conditions that might put you at risk Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBreztri Aerosphere

Budesonide 160 mcg/Glycopyrrolate 7.2 mcg/Formoterol fumarate dehydrate 5 mcg


Locations(1)

Research Site

Hyderabad, India

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NCT06531798