NCT06531798 Post-marketing Phase 4 Safety & Tolerability Study of Breztri aerosphereTM in Indian Patients With Chronic Obstructive Pulmonary Disease
| NCT ID | NCT06531798 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | AstraZeneca |
| Condition | Moderate to Severe COPD |
| Study Type | INTERVENTIONAL |
| Enrollment | 166 participants |
| Start Date | 2026-01-20 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 166 participants in total. It began in 2026-01-20 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06531798 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Moderate to Severe COPD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06531798 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06531798 currently recruiting?
Yes, NCT06531798 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT06531798 trial being conducted?
This trial is being conducted at Bangalore, India, Dalgate, Drugjan, India, Hyderabad, India, Lucknow, India and 2 additional locations.
Who is sponsoring the NCT06531798 clinical trial?
NCT06531798 is sponsored by AstraZeneca. The trial plans to enroll 166 participants.
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