CTRI/2016/11/007460
Completed
Phase 4
A prospective, observational study to evaluate effectiveness and safety of fixed dose combination of Indacaterol maleate 110 mcg and Glycopyrronium bromide 50 mcg in stable Chronic Obstructive Pulmonary Disease (COPD) patients - Ultibro Study
ovartis Healthcare private limited0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis Healthcare private limited
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. COPD patients prescribed with FDC of Indacaterol maleate 110 mcg \+ Glycopyrronium bromide 50 mcg as per discretion of treating physician and as per product prescribing information.
- •2\. Patients willing to participate in the study by providing written informed consent.
Exclusion Criteria
- •1\. Contraindication as per PI
- •2\. Patients simultaneously participating in other studies or use of other investigational drug at the time of enrollment or 5 times the half life of the investigational product prior to visit 1\.
- •Pregnant women should not be included except if, in the opinion of the investigator, the expected benefit outweighs the potential risk to the fetus (please see Section 11 for further information).
Outcomes
Primary Outcomes
Not specified
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