drugset / Trial / NCT06531798
Post-marketing Phase 4 Safety & Tolerability Study of Breztri aerosphereTM in Indian Patients With Chronic Obstructive Pulmonary Disease
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-12-19
- Primary completion
- 2026-10-30
- Completion
- 2027-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Budesonide | Small molecule | 160 ug | Inhaled |
| Subject | Formoterol | Other / unclassified | 5 ug | Inhaled |
| Subject | Glycopyrrolate | Small molecule | 7.2 ug | Inhaled |