Trials / Recruiting
RecruitingNCT06531798
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
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Study details include: The study duration will be 26 weeks The treatment duration will be 24 weeks
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Breztri Aerosphere | Budesonide 160 mcg/Glycopyrrolate 7.2 mcg/Formoterol fumarate dehydrate 5 mcg |
Timeline
- Start date
- 2025-12-19
- Primary completion
- 2026-10-30
- Completion
- 2027-12-30
- First posted
- 2024-08-01
- Last updated
- 2026-03-18
Locations
1 site across 1 country: India
Source: ClinicalTrials.gov record NCT06531798. Inclusion in this directory is not an endorsement.