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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

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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: Not yet recruiting
Phase of Trial: Phase IV

Latest Information Update: 10 Dec 2024

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At a glance

  • Drugs Budesonide/formoterol/glycopyrrolate (Primary)
  • Indications Chronic obstructive pulmonary disease
  • Focus Adverse reactions
  • Acronyms INDOS-B
  • Sponsors AstraZeneca

    • Most Recent Events

    • 06 Dec 2024 Planned End Date changed from 1 Oct 2025 to 30 Dec 2026.
    • 06 Dec 2024 Planned primary completion date changed from 1 Oct 2025 to 30 Oct 2026.
    • 06 Dec 2024 Planned initiation date changed from 1 Sep 2024 to 1 May 2025.

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