Randomized Pragmatic Clinical Trial in a Community-Based Setting Comparing STIOLTO® RESPIMAT® vs. ICS-LABA Plus LAMA in Patients With COPD
Randomized Pragmatic Clinical Trial in a Community-Based Setting Comparing STIOLTO® RESPIMAT® vs. ICS-LABA Plus LAMA in Patients With COPD
The primary objective of this pragmatic study is to compare the time to first moderate or severe COPD exacerbation in patients, not controlled on their current therapy, randomized to Stiolto Respimat versus triple therapy over 12 months of treatment
The secondary objectives of this study include:
Inclusion Criteria:
COPD diagnosis as defined by the study physician
Currently on one of the following maintenance therapies:
Physician determination that patient is not controlled on current pharmacotherapy
Adult patient 40 years of age or older at time of study enrollment
Willingness and ability to understand and provide documented Informed Consent Form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form prior to commencement of any study required assessments, either directly or through Legally Authorized Representative.
Exclusion Criteria: