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]
| Status: | Recruiting | 
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary | 
| Therapuetic Areas: | Pulmonary / Respiratory Diseases | 
| Healthy: | No | 
| Age Range: | 40 - Any | 
| Updated: | 4/4/2019 | 
| Start Date: | September 20, 2017 | 
| End Date: | February 23, 2021 | 
| Contact: | Boehringer Ingelheim | 
| Email: | clintriage.rdg@boehringer-ingelheim.com | 
| Phone: | 1-800-243-0127 | 
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:
1. To compare the annual rate of moderate or severe COPD exacerbations for patients on
Stiolto Respimat with patients on triple therapy.
2. To compare the time to first severe COPD exacerbation in both treatment arms.
3. To compare the annual rate of severe COPD exacerbations in both treatment arms.
4. To compare the proportion of patients with moderate or severe COPD exacerbations in both
treatment arms.
			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:
1. To compare the annual rate of moderate or severe COPD exacerbations for patients on
Stiolto Respimat with patients on triple therapy.
2. To compare the time to first severe COPD exacerbation in both treatment arms.
3. To compare the annual rate of severe COPD exacerbations in both treatment arms.
4. To compare the proportion of patients with moderate or severe COPD exacerbations in both
treatment arms.
Inclusion Criteria:
- 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 Criteria:
- 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.
We found this trial at
    185
    sites
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		University of Iowa With just over 30,000 students, the University of Iowa is one of...  
  
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									8700 Beverly Blvd # 8211
Los Angeles, California 90048
	
			Los Angeles, California 90048
(1-800-233-2771) 
							 
					Phone: +001 (424) 315-2861
					
		Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...  
  
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									1800 Orleans St.
Baltimore, Maryland 21287
	
			Baltimore, Maryland 21287
410-955-5000
							 
					Phone: +001 (410) 550-0546
					
		Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...  
  
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								Bel Air, Maryland 21014			
	
			
					Phone: +001 (410) 288-3115
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									11100 Euclid Ave
Cleveland, Ohio 44106
	
			Cleveland, Ohio 44106
(216) 844-1000
							 
					Phone: +001 (216) 844-3201
					
		University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...  
  
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								Cypress, Texas 77429			
	
			
					Phone: +001 (281) 955-0338
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									24 Hospital Avenue
Danbury, Connecticut 06810
	
			
					Danbury, Connecticut 06810
Phone: +001 (203) 739-8330
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									15300 Jog Road
Delray Beach, Florida 33446
	
			
					Delray Beach, Florida 33446
Phone: +001 (561) 774-2000
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								Dublin, Georgia 31021			
	
			
					Phone: +001 (478) 272-3209
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									546 Towne Drive
Fayetteville, New York 13066
	
			
					Fayetteville, New York 13066
Phone: +001 (315) 234-0816
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									2845 Greenbrier Rd
Green Bay, Wisconsin 54311
	
			Green Bay, Wisconsin 54311
(920) 288-8000
							 
					Phone: +001 (920) 288-8665
					
		Aurora BayCare Medical Center Aurora BayCare Medical Center is a 167-bed, full-service hospital serving the...  
  
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								Hamilton, Ohio 45013			
	
			
					Phone: +001 (513) 893-5864
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								Hendersonville, Tennessee 37075			
	
			
					Phone: +001 (615) 822-2214
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									1038 West North Boulevard
Leesburg, Florida 34748
	
			
					Leesburg, Florida 34748
Phone: +001 (352) 435-7240
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