Post-marketing Phase 4 Safety & Tolerability Study of Breztri aerosphereTM in Indian Patients Wit… (NCT06531798) | Clinical Trial Compass
RecruitingPhase 4
Post-marketing Phase 4 Safety & Tolerability Study of Breztri aerosphereTM in Indian Patients With Chronic Obstructive Pulmonary Disease
India150 participantsStarted 2025-12-19
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
To observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD