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Post-marketing Phase 4 Safety & Tolerability Study of Breztri aerosphereTM in Indian Patients With Chronic Obstructive Pulmonary Disease
Sponsor: AstraZeneca
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-01-30
Completion Date
2027-12-30
Last Updated
2026-08-20
Healthy Volunteers
No
Conditions
Interventions
Breztri Aerosphere
Budesonide 160 mcg/Glycopyrrolate 7.2 mcg/Formoterol fumarate dehydrate 5 mcg
Locations (5)
Research Site
Dalgate, Drugjan, India
Research Site
Hyderabad, India
Research Site
Lucknow, India
Research Site
Nagpur, India
Research Site
New Delhi, India