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

NCT06531798 | Recruiting Phase 4

• 1 other identifier: D5980L00017
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Moderate to Severe COPD

Outcome Measures

Primary Outcomes (1)

• To observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD

  Percentage, nature, intensity, seriousness and causal relationship of AEs, SAEs, and AEs leading to discontinuation of study drug will be assessed

  24 weeks

Study Arms (1)

Single arm

EXPERIMENTAL

It will be a single-arm interventional phase 4 clinical study where participants will receive treatment with Breztri aerosphereTM containing budesonide 160 mcg/ glycopyrronium 7.2 mcg/ formoterol fumarate dehydrate 5 mcg (Breztri aerosphereTM pMDI) two actuations twice daily through oral inhalation for 24 weeks.

Drug: Breztri Aerosphere

Interventions

Breztri Aerosphere DRUG

Budesonide 160 mcg/Glycopyrrolate 7.2 mcg/Formoterol fumarate dehydrate 5 mcg

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a physician-confirmed diagnosis of COPD
• With a history of one severe COPD exacerbation or two or more moderate COPD exacerbations in the preceding 12 months.
• Post-bronchodilator FEV1 should be between ≥30 % to \<80% of the predicted normal.
• Both male and female patients are allowed in the study
• Female of Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal)
• A urine pregnancy test must be negative at screening.
• female participant must follow effective contraceptive method as outlined in protocol
• Patients should be capable of giving signed informed consent

You may not qualify if:

• Significant diseases or conditions other than COPD, which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
• Chest x-ray within 6 months before screening must be acceptable to the investigator. Subjects who have a chest x-ray that reveals clinically significant abnormalities not believed to be due to the presence of COPD should not be included. A chest x-ray must be conducted if the most recent chest x-ray is not available at the time of screening.
• Patients having moderate to severe exacerbations within 6 weeks before the Screening period.
• Female patients who are pregnant or lactating or planning a family during the study period.
• Patients with either a history of hypersensitivity to excipients of the study drug or drugs with a similar chemical structure or class to the study drug.
• Patients participating in any current or future interventional trial during the study will not be enrolled in the current study.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Hyderabad, 500084, India

RECRUITING

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: December 19, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

IN (1)