Not Yet Recruiting PHASE4 INTERVENTIONAL 1-arm NCT06531798

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

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

Conditions Moderate to Severe COPD

Interventions Breztri Aerosphere

Updated 7 times since 2024 Last updated: Oct 29, 2025 Started: Dec 30, 2025 Primary completion: Oct 30, 2026 Completion: Dec 30, 2027

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE4 trial investigates Moderate to Severe COPD and is currently actively recruiting participants. AstraZeneca leads this study, which shows 7 recorded versions since 2025 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

7 versions recorded

Nov 2025 — Present [monthly]

Not Yet Recruiting PHASE4
Oct 2025 — Nov 2025 [monthly]

Not Yet Recruiting PHASE4
Jul 2025 — Oct 2025 [monthly]

Not Yet Recruiting PHASE4
Jun 2025 — Jul 2025 [monthly]

Not Yet Recruiting PHASE4
Jan 2025 — Jun 2025 [monthly]

Not Yet Recruiting PHASE4

▶ Show 2 earlier versions

Sep 2024 — Jan 2025 [monthly]

Not Yet Recruiting PHASE4
Aug 2024 — Sep 2024 [monthly]

Not Yet Recruiting PHASE4

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

AstraZeneca

Data source: AstraZeneca

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.