Post-marketing phase 4 safety & tolerability study of Breztri aerosphereTM in Indian patients with Chronic Obstructive Pulmonary Disease - INDOS-B

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.