Clinical trial NCT03265145: 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]
Official title: Randomized Pragmatic Clinical Trial in a Community-Based Setting Comparing STIOLTO® RESPIMAT® vs. ICS-LABA Plus LAMA in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Carelon Research
First posted: 2017-08-29
Enrollment: 714
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the 12 Month Study Period
timeFrame: Baseline till end of study, up to 12 months.
Secondary outcomes:
measure: Annual Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
timeFrame: Baseline till end of study, up to 12 months.
measure: Time to First Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over 12 Months of Treatment Pulmonary Disease
timeFrame: Baseline till end of study, up to 12 months.
measure: Annual Rate of Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
timeFrame: Baseline till end of study, up to 12 months.
measure: Number of Patients With Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Over the 12 Month Observation Period
timeFrame: 12 months after baseline.
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Pulmonary Associates of Mobile, PC
state: Alabama
city: Montgomery
country: United States
facility: Healthscan Clinical Trials LLC
state: Alabama
city: Montgomery
country: United States
facility: HealthScan Research
state: Alabama
city: Tucson
country: United States
facility: Diamond Childrens Medical Center
state: Arizona
city: Apple Valley
country: United States
facility: CareMore Apple Valley Care Center
state: California
city: Commerce
country: United States
facility: HealthCare Partners
state: California
city: Murrieta
country: United States
facility: Advanced Research Center, Inc.
state: California
city: Newport Beach
country: United States
facility: Newport Native MD, Inc
state: California
city: Rancho Cucamonga
country: United States
facility: Aureus Medical Group, Inc
state: California
city: Roseville
country: United States
facility: Capital Allergy and Respiratory Disease Center
state: California
city: San Juan Capistrano
country: United States
facility: Paloma Medical Group
state: California
city: Torrance
country: United States
facility: Adnab Research/Prestige Care Physician
state: California
city: Brandon
country: United States
facility: Pulmonary and Sleep of Tampa Bay
state: Florida
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Inc.
state: Florida
city: Clearwater
country: United States
facility: Saint Francis Sleep, Allergy and Lung Institute, LLC
state: Florida
city: Delray Beach
country: United States
facility: Cohen Medical Research Associates, LLC
state: Florida
city: Fort Lauderdale
country: United States
facility: Gary J. Richmond, M.D., PA
state: Florida
city: Leesburg
country: United States
facility: Medical Research of Central Florida
state: Florida
city: Lehigh Acres
country: United States
facility: Florida Lung and Sleep Associates
state: Florida
city: Maitland
country: United States
facility: TRY Research
state: Florida
city: Miami
country: United States
facility: Pro Live Medical Research
state: Florida
city: Naples
country: United States
facility: Advanced Research for Health Improvement, LLC
state: Florida
city: Oviedo
country: United States
facility: Oviedo Medical Research
state: Florida
city: Saint Petersburg
country: United States
facility: Pasadena Ctr for Medical Rsrch
state: Florida
city: Sebring
country: United States
facility: Bassetti Medical Research Inc
state: Florida
city: Vero Beach
country: United States
facility: John Suen MD PA
state: Florida
city: Buford
country: United States
facility: Gwinnett Research Institute
state: Georgia
city: Decatur
country: United States
facility: Pulmonary and Sleep Specialists, PC
state: Georgia
city: Marietta
country: United States
facility: DC Pulmonary Medicine
state: Georgia
city: O'Fallon
country: United States
facility: Southern IL Clinical Rsrch Ctr
state: Illinois
city: Franklin
country: United States
facility: American Health Network of Indiana, LLC
state: Indiana
city: Greenfield
country: United States
facility: American Health Network of Indiana, LLC
state: Indiana
city: Michigan City
country: United States
facility: The LaPorte County Institute for Clinical Research
state: Indiana
city: Muncie
country: United States
facility: Ball Memorial Hospital
state: Indiana
city: New Albany
country: United States
facility: American Health Network
state: Indiana
city: Georgetown
country: United States
facility: Kentucky Lung Clinic
state: Kentucky
city: Hopkinsville
country: United States
facility: Pulmonary and Sleep Clinic PLLV
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Bel Air
country: United States
facility: Pulmonary and Critical Care Associates of Baltimore
state: Maryland
city: Towson
country: United States
facility: Pulmonary and Critical Care Associates of Baltimore
state: Maryland
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
city: Dearborn
country: United States
facility: Vida Clinical Studies
state: Michigan
city: Flint
country: United States
facility: Flint Clinical Research
state: Michigan
city: Saint Louis
country: United States
facility: Clayton Sleep Institute
state: Missouri
city: Springfield
country: United States
facility: Mercy Surgery Center
state: Missouri
city: Las Vegas
country: United States
facility: Jubilee Clinical Research, Inc
state: Nevada
city: Ocean City
country: United States
facility: Shore Pulmonary, PA
state: New Jersey
city: Cooperstown
country: United States
facility: Bassett Medical Center
state: New York
city: Fayetteville
country: United States
facility: Pulmonary Health Physicians
state: New York
city: New Hyde Park
country: United States
facility: Feinstein Institute for Medical Research
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Orchard Park
country: United States
facility: Orchard Park Family Practice
state: New York
city: Charlotte
country: United States
facility: American Health Research, Inc.
state: North Carolina
city: Gastonia
country: United States
facility: Clinical Research of Gastonia
state: North Carolina
city: New Bern
country: United States
facility: Coastal Carolina Health Care, P.A.
state: North Carolina
city: Tabor City
country: United States
facility: Tabor City Family Medicine
state: North Carolina
city: Whiteville
country: United States
facility: Goshen Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeastern Research Center
state: North Carolina
city: Blanchester
country: United States
facility: Catherine LaRuffa, MD, Inc.
state: Ohio
city: Centerville
country: United States
facility: Valley Medical Primary Care
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Dayton
country: United States
facility: Midwest Pulmonary and Sleep Research
state: Ohio
city: Englewood
country: United States
facility: Ohio Sleep and Pulmonary Center
state: Ohio
city: Franklin
country: United States
facility: Prestige Clinical Research
state: Ohio
city: Galion
country: United States
facility: Robert Santiago MD, Inc.
state: Ohio
city: Hamilton
country: United States
facility: Pulmonary, Critical Care and Sleep Medicine Associates
state: Ohio
city: Kettering
country: United States
facility: Wells Inst for Hlth Awareness
state: Ohio
city: South Euclid
country: United States
facility: Pulmonary Medicine
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic Incorporated
state: Ohio
city: Willoughby Hills
country: United States
facility: Ohio Clinical Research, LLC
state: Ohio
city: Wooster
country: United States
facility: Comprehensive Internal Medicine, Inc.
state: Ohio
city: Pittsburgh
country: United States
facility: Preferred Primary Care Phys
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Phys
state: Pennsylvania
city: Scottdale
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: Smithfield
country: United States
facility: Frontier Clinical Research LLC
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Phys
state: Pennsylvania
city: Clinton
country: United States
facility: Carolina Medical Research
state: South Carolina
city: Little River
country: United States
facility: Main Street Physicians Care
state: South Carolina
city: Myrtle Beach
country: United States
facility: Family Medicine of SayeBrook
state: South Carolina
city: Cypress
country: United States
facility: Houston Pulmonary Sleep Allergy and Asthma Associates
state: Texas
city: Dallas
country: United States
facility: Texas Health Physicians Group
state: Texas
city: Fort Worth
country: United States
facility: North Texas Lung & Sleep Clnc
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research
state: Texas
city: San Marcos
country: United States
facility: San Marcos Family Medicine
state: Texas
city: Texarkana
country: United States
facility: Texarkana Clinical Research
state: Texas
city: Chesapeake
country: United States
facility: Chesapeake Pulmonary and Critical Care
state: Virginia
city: Richmond
country: United States
facility: Richmond Family Practice
state: Virginia
city: Cheney
country: United States
facility: MultiCare Institute
state: Washington
city: Everett
country: United States
facility: Western Washington Medical Grp
state: Washington
city: Cudahy
country: United States
facility: Pulmonary and Critical Care Associates, SC
state: Wisconsin
Study officials:
References: