Status:
COMPLETED
Assessment In a Real World Setting of the Effect of Inhaled Steroid-based Triple Therapy Versus the Combination of Tiotropium and Olodaterol on Reducing Chronic Obstructive Pulmonary Disease (COPD) Exacerbations [AIRWISE]
Lead Sponsor:
Boehringer Ingelheim
Collaborating Sponsors:
Carelon Research
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- COPD diagnosis as defined by the study physician
- Currently on one of the following maintenance therapies:
- LAMA monotherapy
- LABA monotherapy
- ICS/LABA (FDC)
- 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
- Currently on LAMA/LABA (free or FDC) or triple therapy (ICS plus LABA plus LAMA)
- Contraindication to any study medications (LAMA, LABA or ICS)
- Documented diagnosis of current asthma
- Pregnant or nursing women
- Women of childbearing potential are not restricted in this trial, however it is expected that the investigator will assess the risks and benefits of the assigned treatment as per the product label(s) and discuss this with any women of childbearing potential prior to providing the patient with the prescription for the assigned treatment.
Key Trial Info
Start Date :
September 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2020
Estimated Enrollment :
714 Patients enrolled
Trial Details
Trial ID
NCT03265145
Start Date
September 20 2017
End Date
September 30 2020
Last Update
June 14 2022
Active Locations (90)
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1
Pulmonary Associates of Mobile, PC
Mobile, Alabama, United States, 36608
2
Healthscan Clinical Trials LLC
Montgomery, Alabama, United States, 36106
3
HealthScan Research
Montgomery, Alabama, United States, 36109
4
Diamond Childrens Medical Center
Tucson, Arizona, United States, 85724