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]
Randomized Pragmatic Clinical Trial in a Community-Based Setting Comparing STIOLTO® RESPIMAT® vs. ICS-LABA Plus LAMA in Patients With COPD
1 other identifier
interventional
714
1 country
90
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2017
Typical duration for phase_4
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2017
CompletedFirst Posted
Study publicly available on registry
August 29, 2017
CompletedStudy Start
First participant enrolled
September 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedResults Posted
Study results publicly available
December 9, 2021
CompletedJune 14, 2022
May 1, 2022
3 years
August 25, 2017
September 29, 2021
May 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the 12 Month Study Period
Time to first moderate or severe chronic obstructive (COPD) exacerbation over 12 months of treatment pulmonary disease. Moderate exacerbation was a patient receiving an exacerbation-related prescription such as oral corticosteroid (prednisone or prednisolone) and/or antibiotic, but not requiring hospitalization. Severe exacerbation was a patient requiring hospitalization or emergency room visit due to COPD (ICD-9-491.21 or ICD-10-J44.1). Median survival time as well as 95% confidence interval was calculated using Kaplan-Meier curves.
Baseline till end of study, up to 12 months.
Secondary Outcomes (4)
Annual Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Baseline till end of study, up to 12 months.
Time to First Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over 12 Months of Treatment Pulmonary Disease
Baseline till end of study, up to 12 months.
Annual Rate of Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Baseline till end of study, up to 12 months.
Number of Patients With Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Over the 12 Month Observation Period
12 months after baseline.
Study Arms (2)
Stiolto Respimat
EXPERIMENTALICS plus LABA plus LAMA (triple therapy)
ACTIVE COMPARATORICS (Inhaled Corticosteroid) plus LABA (Long-Acting Beta Agonist) plus (Long-Acting Muscarinic Antagonist)
Interventions
Duration - 12 months
Duration - 12 months
Duration - 12 months
Duration - 12 months
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boehringer Ingelheimlead
- Carelon Researchcollaborator
Study Sites (90)
Pulmonary Associates of Mobile, PC
Mobile, Alabama, 36608, United States
Healthscan Clinical Trials LLC
Montgomery, Alabama, 36106, United States
HealthScan Research
Montgomery, Alabama, 36109, United States
Diamond Childrens Medical Center
Tucson, Arizona, 85724, United States
CareMore Apple Valley Care Center
Apple Valley, California, 92308, United States
HealthCare Partners
Commerce, California, 90040, United States
Advanced Research Center, Inc.
Murrieta, California, 92562, United States
Newport Native MD, Inc
Newport Beach, California, 92663, United States
Aureus Medical Group, Inc
Rancho Cucamonga, California, 91730, United States
Capital Allergy and Respiratory Disease Center
Roseville, California, 95661, United States
Paloma Medical Group
San Juan Capistrano, California, 92675, United States
Adnab Research/Prestige Care Physician
Torrance, California, 90505, United States
Pulmonary and Sleep of Tampa Bay
Brandon, Florida, 33511, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756, United States
Saint Francis Sleep, Allergy and Lung Institute, LLC
Clearwater, Florida, 33765, United States
Cohen Medical Research Associates, LLC
Delray Beach, Florida, 33446, United States
Gary J. Richmond, M.D., PA
Fort Lauderdale, Florida, 33316, United States
Medical Research of Central Florida
Leesburg, Florida, 34748, United States
Florida Lung and Sleep Associates
Lehigh Acres, Florida, 33971, United States
TRY Research
Maitland, Florida, 32751, United States
Pro Live Medical Research
Miami, Florida, 33175, United States
Advanced Research for Health Improvement, LLC
Naples, Florida, 34102, United States
Oviedo Medical Research
Oviedo, Florida, 32765, United States
Bassetti Medical Research Inc
Sebring, Florida, 33870, United States
Pasadena Ctr for Medical Rsrch
St. Petersburg, Florida, 33707, United States
John Suen MD PA
Vero Beach, Florida, 32960, United States
Gwinnett Research Institute
Buford, Georgia, 30519, United States
Pulmonary and Sleep Specialists, PC
Decatur, Georgia, 30033, United States
DC Pulmonary Medicine
Marietta, Georgia, 30060, United States
Southern IL Clinical Rsrch Ctr
O'Fallon, Illinois, 62269, United States
American Health Network of Indiana, LLC
Franklin, Indiana, 46131, United States
American Health Network of Indiana, LLC
Greenfield, Indiana, 46140, United States
The LaPorte County Institute for Clinical Research
Michigan City, Indiana, 46360, United States
Ball Memorial Hospital
Muncie, Indiana, 47303, United States
American Health Network
New Albany, Indiana, 47150, United States
Kentucky Lung Clinic
Georgetown, Kentucky, 40324, United States
Pulmonary and Sleep Clinic PLLV
Hopkinsville, Kentucky, 42240, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21224, United States
Pulmonary and Critical Care Associates of Baltimore
Bel Air, Maryland, 21014, United States
Pulmonary and Critical Care Associates of Baltimore
Towson, Maryland, 21286, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
Vida Clinical Studies
Dearborn, Michigan, 48124, United States
Flint Clinical Research
Flint, Michigan, 48503, United States
Mercy Surgery Center
Springfield, Missouri, 65804, United States
Clayton Sleep Institute
St Louis, Missouri, 63123, United States
Jubilee Clinical Research, Inc
Las Vegas, Nevada, 89106, United States
Shore Pulmonary, PA
Ocean City, New Jersey, 07712, United States
Bassett Medical Center
Cooperstown, New York, 13326, United States
Pulmonary Health Physicians
Fayetteville, New York, 13066, United States
Feinstein Institute for Medical Research
New Hyde Park, New York, 11040, United States
Lenox Hill Hospital
New York, New York, 10021, United States
Orchard Park Family Practice
Orchard Park, New York, 14127, United States
American Health Research, Inc.
Charlotte, North Carolina, 28207, United States
Clinical Research of Gastonia
Gastonia, North Carolina, 28054, United States
Coastal Carolina Health Care, P.A.
New Bern, North Carolina, 28562, United States
Tabor City Family Medicine
Tabor City, North Carolina, 28463, United States
Goshen Medical Center
Whiteville, North Carolina, 28472, United States
Southeastern Research Center
Winston-Salem, North Carolina, 27103, United States
Catherine LaRuffa, MD, Inc.
Blanchester, Ohio, 45107, United States
Valley Medical Primary Care
Centerville, Ohio, 45459, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Midwest Pulmonary and Sleep Research
Dayton, Ohio, 45459, United States
Ohio Sleep and Pulmonary Center
Englewood, Ohio, 45322, United States
Prestige Clinical Research
Franklin, Ohio, 45005, United States
Robert Santiago MD, Inc.
Galion, Ohio, 44833, United States
Pulmonary, Critical Care and Sleep Medicine Associates
Hamilton, Ohio, 45013, United States
Wells Inst for Hlth Awareness
Kettering, Ohio, 45429, United States
Pulmonary Medicine
South Euclid, Ohio, 44121, United States
Toledo Clinic Incorporated
Toledo, Ohio, 43623, United States
Ohio Clinical Research, LLC
Willoughby Hills, Ohio, 44094, United States
Comprehensive Internal Medicine, Inc.
Wooster, Ohio, 44691, United States
Preferred Primary Care Phys
Pittsburgh, Pennsylvania, 15236, United States
Preferred Primary Care Phys
Pittsburgh, Pennsylvania, 15243, United States
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, 15683, United States
Frontier Clinical Research LLC
Smithfield, Pennsylvania, 15478, United States
Preferred Primary Care Phys
Uniontown, Pennsylvania, 15401, United States
Carolina Medical Research
Clinton, South Carolina, 29325, United States
Main Street Physicians Care
Little River, South Carolina, 29566, United States
Family Medicine of SayeBrook
Myrtle Beach, South Carolina, 29588, United States
Houston Pulmonary Sleep Allergy and Asthma Associates
Cypress, Texas, 77429, United States
Texas Health Physicians Group
Dallas, Texas, 75243, United States
North Texas Lung & Sleep Clnc
Fort Worth, Texas, 76109, United States
SMS Clinical Research
Mesquite, Texas, 75149, United States
San Marcos Family Medicine
San Marcos, Texas, 78666, United States
Texarkana Clinical Research
Texarkana, Texas, 75503, United States
Chesapeake Pulmonary and Critical Care
Chesapeake, Virginia, 23320, United States
Richmond Family Practice
Richmond, Virginia, 23220, United States
MultiCare Institute
Cheney, Washington, 99004, United States
Western Washington Medical Grp
Everett, Washington, 98208, United States
Pulmonary and Critical Care Associates, SC
Cudahy, Wisconsin, 53110, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2017
First Posted
August 29, 2017
Study Start
September 20, 2017
Primary Completion
September 30, 2020
Study Completion
September 30, 2020
Last Updated
June 14, 2022
Results First Posted
December 9, 2021
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
- Access Criteria
- For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.