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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: Stiolto Respimat; Drug: ICS (Inhaled Corticosteroid) (Triple therapy); Drug: LABA (Long-Acting Beta Agonist) (Triple therapy); Drug: LAMA (Long-Acting Muscarinic Antagonist) (Triple therapy)

• Study Type: Interventional
• Enrollment (Actual): 714
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Pulmonary Associates of Mobile, PC
    • Montgomery, Alabama, United States, 36106
      • Healthscan Clinical Trials LLC
    • Montgomery, Alabama, United States, 36109
      • Healthscan Research
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Diamond Childrens Medical Center
  • California
    • Apple Valley, California, United States, 92308
      • CareMore Apple Valley Care Center
    • Commerce, California, United States, 90040
      • Healthcare Partners
    • Murrieta, California, United States, 92562
      • Advanced Research Center, Inc.
    • Newport Beach, California, United States, 92663
      • Newport Native MD, Inc
    • Rancho Cucamonga, California, United States, 91730
      • Aureus Medical Group, Inc
    • Roseville, California, United States, 95661
      • Capital Allergy and Respiratory Disease Center
    • San Juan Capistrano, California, United States, 92675
      • Paloma Medical Group
    • Torrance, California, United States, 90505
      • Adnab Research/Prestige Care Physician
  • Florida
    • Brandon, Florida, United States, 33511
      • Pulmonary and Sleep of Tampa Bay
    • Clearwater, Florida, United States, 33756
      • Innovative Research Of West Florida, Inc.
    • Clearwater, Florida, United States, 33765
      • Saint Francis Sleep, Allergy and Lung Institute, LLC
    • Delray Beach, Florida, United States, 33446
      • Cohen Medical Research Associates, LLC
    • Fort Lauderdale, Florida, United States, 33316
      • Gary J. Richmond, M.D., PA
    • Leesburg, Florida, United States, 34748
      • Medical Research of Central Florida
    • Lehigh Acres, Florida, United States, 33971
      • Florida Lung and Sleep Associates
    • Maitland, Florida, United States, 32751
      • Try Research
    • Miami, Florida, United States, 33175
      • Pro Live Medical Research
    • Naples, Florida, United States, 34102
      • Advanced Research for Health Improvement, LLC
    • Oviedo, Florida, United States, 32765
      • Oviedo Medical Research
    • Saint Petersburg, Florida, United States, 33707
      • Pasadena Ctr for Medical Rsrch
    • Sebring, Florida, United States, 33870
      • Bassetti Medical Research Inc
    • Vero Beach, Florida, United States, 32960
      • John Suen MD PA
  • Georgia
    • Buford, Georgia, United States, 30519
      • Gwinnett Research Institute
    • Decatur, Georgia, United States, 30033
      • Pulmonary and Sleep Specialists, PC
    • Marietta, Georgia, United States, 30060
      • DC Pulmonary Medicine
  • Illinois
    • O'Fallon, Illinois, United States, 62269
      • Southern IL Clinical Rsrch Ctr
  • Indiana
    • Franklin, Indiana, United States, 46131
      • American Health Network of Indiana, LLC
    • Greenfield, Indiana, United States, 46140
      • American Health Network of Indiana, LLC
    • Michigan City, Indiana, United States, 46360
      • The LaPorte County Institute for Clinical Research
    • Muncie, Indiana, United States, 47303
      • Ball Memorial Hospital
    • New Albany, Indiana, United States, 47150
      • American Health Network
  • Kentucky
    • Georgetown, Kentucky, United States, 40324
      • Kentucky Lung Clinic
    • Hopkinsville, Kentucky, United States, 42240
      • Pulmonary and Sleep Clinic PLLV
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Hospital
    • Bel Air, Maryland, United States, 21014
      • Pulmonary and Critical Care Associates of Baltimore
    • Towson, Maryland, United States, 21286
      • Pulmonary and Critical Care Associates of Baltimore
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Hospital and Medical Center
  • Michigan
    • Dearborn, Michigan, United States, 48124
      • Vida Clinical Studies
    • Flint, Michigan, United States, 48503
      • Flint Clinical Research
  • Missouri
    • Saint Louis, Missouri, United States, 63123
      • Clayton Sleep Institute
    • Springfield, Missouri, United States, 65804
      • Mercy Surgery Center
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Jubilee Clinical Research, Inc
  • New Jersey
    • Ocean City, New Jersey, United States, 07712
      • Shore Pulmonary, PA
  • New York
    • Cooperstown, New York, United States, 13326
      • Bassett Medical Center
    • Fayetteville, New York, United States, 13066
      • Pulmonary Health Physicians
    • New Hyde Park, New York, United States, 11040
      • Feinstein Institute for Medical Research
    • New York, New York, United States, 10021
      • Lenox Hill Hospital
    • Orchard Park, New York, United States, 14127
      • Orchard Park Family Practice
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • American Health Research, Inc.
    • Gastonia, North Carolina, United States, 28054
      • Clinical Research of Gastonia
    • New Bern, North Carolina, United States, 28562
      • Coastal Carolina Health Care, P.A.
    • Tabor City, North Carolina, United States, 28463
      • Tabor City Family Medicine
    • Whiteville, North Carolina, United States, 28472
      • Goshen Medical Center
    • Winston-Salem, North Carolina, United States, 27103
      • Southeastern Research Center
  • Ohio
    • Blanchester, Ohio, United States, 45107
      • Catherine LaRuffa, MD, Inc.
    • Centerville, Ohio, United States, 45459
      • Valley Medical Primary Care
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Of Cleveland
    • Dayton, Ohio, United States, 45459
      • Midwest Pulmonary and Sleep Research
    • Englewood, Ohio, United States, 45322
      • Ohio Sleep and Pulmonary Center
    • Franklin, Ohio, United States, 45005
      • Prestige Clinical Research
    • Galion, Ohio, United States, 44833
      • Robert Santiago MD, Inc.
    • Hamilton, Ohio, United States, 45013
      • Pulmonary, Critical Care and Sleep Medicine Associates
    • Kettering, Ohio, United States, 45429
      • Wells Inst for Hlth Awareness
    • South Euclid, Ohio, United States, 44121
      • Pulmonary Medicine
    • Toledo, Ohio, United States, 43623
      • Toledo Clinic Incorporated
    • Willoughby Hills, Ohio, United States, 44094
      • Ohio Clinical Research, LLC
    • Wooster, Ohio, United States, 44691
      • Comprehensive Internal Medicine, Inc.
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15236
      • Preferred Primary Care Phys
    • Pittsburgh, Pennsylvania, United States, 15243
      • Preferred Primary Care Phys
    • Scottdale, Pennsylvania, United States, 15683
      • Frontier Clinical Research, LLC
    • Smithfield, Pennsylvania, United States, 15478
      • Frontier Clinical Research LLC
    • Uniontown, Pennsylvania, United States, 15401
      • Preferred Primary Care Phys
  • South Carolina
    • Clinton, South Carolina, United States, 29325
      • Carolina Medical Research
    • Little River, South Carolina, United States, 29566
      • Main Street Physicians Care
    • Myrtle Beach, South Carolina, United States, 29588
      • Family Medicine of Sayebrook
  • Texas
    • Cypress, Texas, United States, 77429
      • Houston Pulmonary Sleep Allergy and Asthma Associates
    • Dallas, Texas, United States, 75243
      • Texas Health Physicians Group
    • Fort Worth, Texas, United States, 76109
      • North Texas Lung & Sleep Clnc
    • Mesquite, Texas, United States, 75149
      • SMS Clinical Research
    • San Marcos, Texas, United States, 78666
      • San Marcos Family Medicine
    • Texarkana, Texas, United States, 75503
      • Texarkana Clinical Research
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Chesapeake Pulmonary and Critical Care
    • Richmond, Virginia, United States, 23220
      • Richmond Family Practice
  • Washington
    • Cheney, Washington, United States, 99004
      • MultiCare Institute
    • Everett, Washington, United States, 98208
      • Western Washington Medical Grp
  • Wisconsin
    • Cudahy, Wisconsin, United States, 53110
      • Pulmonary and Critical Care Associates, SC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Stiolto Respimat	Drug: Stiolto Respimat; Duration - 12 months; Other Names: INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO
ACTIVE_COMPARATOR: ICS plus LABA plus LAMA (triple therapy); ICS (Inhaled Corticosteroid) plus LABA (Long-Acting Beta Agonist) plus (Long-Acting Muscarinic Antagonist)	Drug: ICS (Inhaled Corticosteroid) (Triple therapy); Duration - 12 months; Drug: LABA (Long-Acting Beta Agonist) (Triple therapy); Duration - 12 months; Drug: LAMA (Long-Acting Muscarinic Antagonist) (Triple therapy); Duration - 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annual Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations	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.	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	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.	Baseline till end of study, up to 12 months.
Annual Rate of Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations	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.	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	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).	12 months after baseline.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim
• Collaborators: HealthCore-NERI

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 20, 2017
• Primary Completion (ACTUAL): September 30, 2020
• Study Completion (ACTUAL): September 30, 2020

Study Registration Dates

• First Submitted: August 25, 2017
• First Submitted That Met QC Criteria: August 25, 2017
• First Posted (ACTUAL): August 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Antagonists; Muscarinic Antagonists; Cholinergic Agents
• Other Study ID Numbers: 1237-0064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No