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]
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Drug: ICS (Inhaled Corticosteroid) (Triple therapy)Drug: Stiolto RespimatDrug: LABA (Long-Acting Beta Agonist) (Triple therapy)Drug: LAMA (Long-Acting Muscarinic Antagonist) (Triple therapy)
- Registration Number
- NCT03265145
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 714
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ICS plus LABA plus LAMA (triple therapy) ICS (Inhaled Corticosteroid) (Triple therapy) ICS (Inhaled Corticosteroid) plus LABA (Long-Acting Beta Agonist) plus (Long-Acting Muscarinic Antagonist) Stiolto Respimat Stiolto Respimat - ICS plus LABA plus LAMA (triple therapy) LAMA (Long-Acting Muscarinic Antagonist) (Triple therapy) ICS (Inhaled Corticosteroid) plus LABA (Long-Acting Beta Agonist) plus (Long-Acting Muscarinic Antagonist) ICS plus LABA plus LAMA (triple therapy) LABA (Long-Acting Beta Agonist) (Triple therapy) ICS (Inhaled Corticosteroid) plus LABA (Long-Acting Beta Agonist) plus (Long-Acting Muscarinic Antagonist)
- Primary Outcome Measures
Name Time Method Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the 12 Month Study Period Baseline till end of study, up to 12 months. 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.
- Secondary Outcome Measures
Name Time Method 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. Time to first 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.Annual Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Baseline till end of study, up to 12 months. Annual rate of moderate or severe chronic obstructive pulmonary disease (COPD) exacerbations.
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).
Annual rate analysis utilized a negative binomial model with fixed effect of treatment (Stiolto Respimat versus triple therapy), logarithm of observational time as offset, and baseline prior ICS was used as a covariate.Annual Rate of Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Baseline till end of study, up to 12 months. Annual rate of severe chronic obstructive pulmonary disease (COPD) exacerbations.
Severe exacerbation was a patient requiring hospitalization or emergency room visit due to COPD (ICD-9-491.21 or ICD-10-J44.1).
Annual rate analysis utilized a negative binomial model with fixed effect of treatment (Stiolto Respimat versus triple therapy), logarithm of observational time as offset, and baseline prior ICS was used as a covariate.Number of Patients With Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Over the 12 Month Observation Period 12 months after baseline. Number of patients with moderate or severe chronic obstructive pulmonary disease (COPD) exacerbations over the 12 month observation period.
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).
Trial Locations
- Locations (86)
Aureus Medical Group, Inc
🇺🇸Rancho Cucamonga, California, United States
HealthCare Partners
🇺🇸Commerce, California, United States
Advanced Research for Health Improvement, LLC
🇺🇸Naples, Florida, United States
Healthscan Clinical Trials LLC
🇺🇸Montgomery, Alabama, United States
CareMore Apple Valley Care Center
🇺🇸Apple Valley, California, United States
TRY Research
🇺🇸Maitland, Florida, United States
Paloma Medical Group
🇺🇸San Juan Capistrano, California, United States
Diamond Childrens Medical Center
🇺🇸Tucson, Arizona, United States
Oviedo Medical Research
🇺🇸Oviedo, Florida, United States
Tabor City Family Medicine
🇺🇸Tabor City, North Carolina, United States
Advanced Research Center, Inc.
🇺🇸Murrieta, California, United States
Flint Clinical Research
🇺🇸Flint, Michigan, United States
Pulmonary and Critical Care Associates of Baltimore
🇺🇸Towson, Maryland, United States
Gwinnett Research Institute
🇺🇸Buford, Georgia, United States
Ball Memorial Hospital
🇺🇸Muncie, Indiana, United States
Pulmonary Health Physicians
🇺🇸Fayetteville, New York, United States
Valley Medical Primary Care
🇺🇸Centerville, Ohio, United States
Pulmonary, Critical Care and Sleep Medicine Associates
🇺🇸Hamilton, Ohio, United States
Pulmonary and Critical Care Associates, SC
🇺🇸Cudahy, Wisconsin, United States
North Texas Lung & Sleep Clnc
🇺🇸Fort Worth, Texas, United States
Western Washington Medical Grp
🇺🇸Everett, Washington, United States
Pulmonary Associates of Mobile, PC
🇺🇸Mobile, Alabama, United States
Newport Native MD, Inc
🇺🇸Newport Beach, California, United States
Adnab Research/Prestige Care Physician
🇺🇸Torrance, California, United States
Innovative Research of West Florida, Inc.
🇺🇸Clearwater, Florida, United States
Saint Francis Sleep, Allergy and Lung Institute, LLC
🇺🇸Clearwater, Florida, United States
Gary J. Richmond, M.D., PA
🇺🇸Fort Lauderdale, Florida, United States
Pulmonary and Sleep Specialists, PC
🇺🇸Decatur, Georgia, United States
DC Pulmonary Medicine
🇺🇸Marietta, Georgia, United States
Southern IL Clinical Rsrch Ctr
🇺🇸O'Fallon, Illinois, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Mercy Surgery Center
🇺🇸Springfield, Missouri, United States
Ohio Sleep and Pulmonary Center
🇺🇸Englewood, Ohio, United States
Wells Inst for Hlth Awareness
🇺🇸Kettering, Ohio, United States
Pro Live Medical Research
🇺🇸Miami, Florida, United States
HealthScan Research
🇺🇸Montgomery, Alabama, United States
Capital Allergy and Respiratory Disease Center
🇺🇸Roseville, California, United States
Pulmonary and Sleep of Tampa Bay
🇺🇸Brandon, Florida, United States
Medical Research of Central Florida
🇺🇸Leesburg, Florida, United States
Cohen Medical Research Associates, LLC
🇺🇸Delray Beach, Florida, United States
Bassetti Medical Research Inc
🇺🇸Sebring, Florida, United States
Pulmonary and Sleep Clinic PLLV
🇺🇸Hopkinsville, Kentucky, United States
Clayton Sleep Institute
🇺🇸Saint Louis, Missouri, United States
Orchard Park Family Practice
🇺🇸Orchard Park, New York, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Comprehensive Internal Medicine, Inc.
🇺🇸Wooster, Ohio, United States
Frontier Clinical Research, LLC
🇺🇸Scottdale, Pennsylvania, United States
Pulmonary Medicine
🇺🇸South Euclid, Ohio, United States
Texas Health Physicians Group
🇺🇸Dallas, Texas, United States
Texarkana Clinical Research
🇺🇸Texarkana, Texas, United States
Chesapeake Pulmonary and Critical Care
🇺🇸Chesapeake, Virginia, United States
Vida Clinical Studies
🇺🇸Dearborn, Michigan, United States
Carolina Medical Research
🇺🇸Clinton, South Carolina, United States
Family Medicine of SayeBrook
🇺🇸Myrtle Beach, South Carolina, United States
Jubilee Clinical Research, Inc
🇺🇸Las Vegas, Nevada, United States
Shore Pulmonary, PA
🇺🇸Ocean City, New Jersey, United States
Main Street Physicians Care
🇺🇸Little River, South Carolina, United States
The LaPorte County Institute for Clinical Research
🇺🇸Michigan City, Indiana, United States
American Health Network
🇺🇸New Albany, Indiana, United States
Pasadena Ctr for Medical Rsrch
🇺🇸Saint Petersburg, Florida, United States
American Health Network of Indiana, LLC
🇺🇸Greenfield, Indiana, United States
Feinstein Institute for Medical Research
🇺🇸New Hyde Park, New York, United States
Clinical Research of Gastonia
🇺🇸Gastonia, North Carolina, United States
American Health Research, Inc.
🇺🇸Charlotte, North Carolina, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
Bassett Medical Center
🇺🇸Cooperstown, New York, United States
Southeastern Research Center
🇺🇸Winston-Salem, North Carolina, United States
Coastal Carolina Health Care, P.A.
🇺🇸New Bern, North Carolina, United States
Catherine LaRuffa, MD, Inc.
🇺🇸Blanchester, Ohio, United States
Goshen Medical Center
🇺🇸Whiteville, North Carolina, United States
Prestige Clinical Research
🇺🇸Franklin, Ohio, United States
Midwest Pulmonary and Sleep Research
🇺🇸Dayton, Ohio, United States
Robert Santiago MD, Inc.
🇺🇸Galion, Ohio, United States
Houston Pulmonary Sleep Allergy and Asthma Associates
🇺🇸Cypress, Texas, United States
Lahey Hospital and Medical Center
🇺🇸Burlington, Massachusetts, United States
SMS Clinical Research
🇺🇸Mesquite, Texas, United States
San Marcos Family Medicine
🇺🇸San Marcos, Texas, United States
Ohio Clinical Research, LLC
🇺🇸Willoughby Hills, Ohio, United States
Preferred Primary Care Phys
🇺🇸Uniontown, Pennsylvania, United States
Frontier Clinical Research LLC
🇺🇸Smithfield, Pennsylvania, United States
Richmond Family Practice
🇺🇸Richmond, Virginia, United States
Toledo Clinic Incorporated
🇺🇸Toledo, Ohio, United States
John Suen MD PA
🇺🇸Vero Beach, Florida, United States
Florida Lung and Sleep Associates
🇺🇸Lehigh Acres, Florida, United States
MultiCare Institute
🇺🇸Cheney, Washington, United States
Kentucky Lung Clinic
🇺🇸Georgetown, Kentucky, United States