Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Zydus Healthcare Ltd. India
Eligibility
Inclusion criteria
Inclusion criteria: Eligible for single inhaler triple therapy (LABA + LAMA + ICS) as per clinicianââ?¬•s discretion Gives signed written informed consent to participate. For Female patients A female is eligible to enter and participate in the study if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal) For females with childbearing potential, who agrees for contraception throughout - from Visit 1 (Screening) till 1 month after the final visit)
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse & Serious Adverse events during the study period Spirometry measures Change in COPD Assessment Test Change in modified Medical Research Council Dyspnoea Scale Change in Clinical COPD Questionnaire Number of severe exacerbations needing hospitalizations Use of rescue medications (SABA pMDI) during the study periodTimepoint: Baseline, 4 weeks & 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Shwetal Sanghvi
Insignia Communications Pvt. Ltd.
Outcome results
None listed