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

Study acronym: INDOS-B
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment increased: 150 → 166 participants Study sites: 5 to 6 · Start date: Jan 30, 2026 to Jan 20, 2026 · Eligibility criteria expanded, about 13 words Show 3 more changesShow less
    • Study sites: 5 to 6
    • Start date: Jan 30, 2026 to Jan 20, 2026
    • Eligibility criteria expanded, about 13 words
  2. Site details revised at 1 of 5 sitesv10
  3. Start date: Dec 19, 2025 to Jan 30, 2026 Trial sites expanded: 1 → 5 locationsv9 Show 1 more changeShow less
    • Trial sites expanded: 1 → 5 locations
  4. Re-verified, no change to tracked fieldsv8
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Dec 30, 2025 to Dec 19, 2025v7 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 30, 2025 to Dec 19, 2025
Show 5 earlier versionsHide 5 earlier versions
  1. Start date: Oct 30, 2025 to Dec 30, 2025v6
  2. Start date: Jul 30, 2025 to Oct 30, 2025 Completion date: Jul 30, 2027 to Dec 30, 2027v5 Show 1 more changeShow less
    • Completion date: Jul 30, 2027 to Dec 30, 2027
  3. Start date: May 1, 2025 to Jul 30, 2025 Completion date: Dec 30, 2026 to Jul 30, 2027v4 Show 1 more changeShow less
    • Completion date: Dec 30, 2026 to Jul 30, 2027
  4. Re-verified, no change to tracked fieldsv3
  5. Primary completion date: Oct 1, 2025 to Oct 30, 2026 Start date: Sep 1, 2024 to May 1, 2025 · Completion date: Oct 1, 2025 to Dec 30, 2026v2 Show 2 more changesShow less
    • Start date: Sep 1, 2024 to May 1, 2025
    • Completion date: Oct 1, 2025 to Dec 30, 2026
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AstraZeneca
727 trials monitored
See 61 trials at risk
COPD
1,068 trials monitored
See 31 trials at risk
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.
Trial Details
NCT Number NCT06531798
Lead Sponsor AstraZeneca
Conditions Moderate to Severe COPD
Enrollment 166 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov