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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]

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ClinicalTrials.gov Identifier: NCT03265145
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : March 20, 2019
Sponsor:
Collaborator:
Healthcore
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive 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) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Pragmatic Clinical Trial in a Community-Based Setting Comparing STIOLTO® RESPIMAT® vs. ICS-LABA Plus LAMA in Patients With COPD
Actual Study Start Date : September 20, 2017
Estimated Primary Completion Date : February 23, 2021
Estimated Study Completion Date : February 23, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Stiolto Respimat Drug: Stiolto Respimat
Duration - 12 months
Other Name: 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




Primary Outcome Measures :
  1. Time to first moderate or severe chronic obstructive pulmonary disease (COPD) exacerbation [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Annual rate of moderate or severe chronic obstructive pulmonary disease (COPD) exacerbations [ Time Frame: 12 months ]
  2. Time to first severe chronic obstructive pulmonary disease (COPD) exacerbation [ Time Frame: 12 months ]
  3. Annual rate of severe chronic obstructive pulmonary disease (COPD) exacerbations [ Time Frame: 12 months ]
  4. Proportion of patients with moderate or severe chronic obstructive pulmonary disease (COPD) exacerbations [ Time Frame: 12 months ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265145


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

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Locations
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United States, Alabama
Clinical Research Center of AL Recruiting
Birmingham, Alabama, United States, 35209
Contact: John Anderson    +001 (205) 204-4134    janderson@alabamaallergy.com   
Pulmonary Associates of Mobile, PC Active, not recruiting
Mobile, Alabama, United States, 36608
Healthscan Clinical Trials LLC Active, not recruiting
Montgomery, Alabama, United States, 36106
United States, Arizona
Clinical Trial Connection Recruiting
Flagstaff, Arizona, United States, 86001
Contact: Douglas Mapel    +001 (928) 637-6614    ctcdmapel@aol.com   
United States, California
HealthCare Partners Active, not recruiting
Commerce, California, United States, 90040
The Probe Recruiting
Los Angeles, California, United States, 90004
Contact: Arnel Joaquin    +001 (323) 391-8310    dr.joaquin@theprobemedicalresearch.com   
Advanced Research Center, Inc. Active, not recruiting
Murrieta, California, United States, 92562
Newport Native MD, Inc Active, not recruiting
Newport Beach, California, United States, 92663
Capital Allergy and Respiratory Disease Center Recruiting
Roseville, California, United States, 95661
Contact: Neil Parikh    +001 (916) 233-2628    nparikh@capitalallergy.com   
Paloma Medical Group Active, not recruiting
San Juan Capistrano, California, United States, 92675
Adnab Research/Prestige Care Physician Recruiting
Torrance, California, United States, 90505
Contact: Hicham Siouty    +001 (562) 322-4399    gmmelendrez@gmail.com   
United States, Connecticut
Waterbury Pulmonary Associates LLC Recruiting
Waterbury, Connecticut, United States, 06708
Contact: David Hill    +001 (203) 759-3656    Davidhill66@gmail.com   
United States, Florida
Pulmonary and Sleep of Tampa Bay Active, not recruiting
Brandon, Florida, United States, 33511
Innovative Research of West Florida, Inc. Active, not recruiting
Clearwater, Florida, United States, 33756
Saint Francis Sleep, Allergy and Lung Institute, LLC Active, not recruiting
Clearwater, Florida, United States, 33765
Lake Internal Medicine Associates Recruiting
Eustis, Florida, United States, 32726
Contact: Steven Tang    +001 (352) 589-4774    stang@steventangmd.com   
Gary J. Richmond, M.D., PA Terminated
Fort Lauderdale, Florida, United States, 33316
TRY Research Completed
Maitland, Florida, United States, 32751
Universal Axon Clinical Research Recruiting
Miami, Florida, United States, 33166
Contact: Luis Martinez    +001 (305) 677-9267    Lmartinez@uaclinical.com   
Pro Live Medical Research Active, not recruiting
Miami, Florida, United States, 33175
Advanced Research for Health Improvement, LLC Recruiting
Naples, Florida, United States, 34102
Contact: Lisette Delgado Sanchez    +001 (239) 230-2021    juan.ramos@arhiusa.com   
Omega Research Orlando, LLC Recruiting
Orlando, Florida, United States, 32808
Contact: Kwabena Ayesu    +001 (407) 512-1054    kayesu@omegarcllc.com   
Oviedo Medical Research Recruiting
Oviedo, Florida, United States, 32765
Contact: Bradley Block    +001 (407) 977-2705    docblock@oviedomedicalresearch.com   
Pasadena Ctr for Medical Rsrch Active, not recruiting
Saint Petersburg, Florida, United States, 33707
John Suen MD PA Active, not recruiting
Vero Beach, Florida, United States, 32960
United States, Georgia
Gwinnett Research Institute Recruiting
Buford, Georgia, United States, 30519
Contact: Alexander Osowa    +001 (470) 326-3358    alex.osowa@gwinnettresearchinstitute.com   
Pulmonary and Sleep Specialists, PC Active, not recruiting
Decatur, Georgia, United States, 30033
Pulmonology, Sleep, Asthma and Allergy Center of Dublin Recruiting
Dublin, Georgia, United States, 31021
Contact: Vishal Agrawal    +001 (478) 272-3209    agrawav@gmail.com   
Southern Lung Specialists, PC Recruiting
Macon, Georgia, United States, 31201
Contact: Gerald Tarirah    +001 (478) 745-9998    geraldtarira@yahoo.com   
DC Pulmonary Medicine Active, not recruiting
Marietta, Georgia, United States, 30060
United States, Illinois
Southern IL Clinical Rsrch Ctr Active, not recruiting
O'Fallon, Illinois, United States, 62269
United States, Indiana
American Health Network Active, not recruiting
Avon, Indiana, United States, 46123
American Health Network of Indiana, LLC Active, not recruiting
Franklin, Indiana, United States, 46131
American Health Network of Indiana, LLC Recruiting
Greenfield, Indiana, United States, 46140
Contact: Talessa Powell    +001 (317) 462-5252    Talessa_Powell@ahni.com   
The LaPorte County Institute for Clinical Research Completed
Michigan City, Indiana, United States, 46360
Ball Memorial Hospital Active, not recruiting
Muncie, Indiana, United States, 47303
American Health Network of Indiana, LLC Recruiting
Muncie, Indiana, United States, 47304
Contact: Jonathan Condit    +001 (765) 213-2876    Jon_Condit@ahni.com   
American Health Network Active, not recruiting
New Albany, Indiana, United States, 47150
United States, Kentucky
Kentucky Lung Clinic Active, not recruiting
Georgetown, Kentucky, United States, 40324
Pulmonary and Sleep Clinic PLLV Completed
Hopkinsville, Kentucky, United States, 42240
Louisville Pulmonary Care Recruiting
Louisville, Kentucky, United States, 40207
Contact: Harold Haller    +001 (502) 744-8142    hdhjrmd@gmail.com   
United States, Maine
Office of Dr. Paul A. Shapero Recruiting
Bangor, Maine, United States, 04401
Contact: Paul Shapero    +001 (207) 947-8658    allergyme@gmail.com   
United States, Maryland
Pulmonary and Critical Care Associates of Baltimore Active, not recruiting
Bel Air, Maryland, United States, 21014
Pulmonary and Critical Care Associates of Baltimore Active, not recruiting
Towson, Maryland, United States, 21286
United States, Michigan
Flint Clinical Research Completed
Flint, Michigan, United States, 48503
United States, Missouri
Clayton Sleep Institute Recruiting
Saint Louis, Missouri, United States, 63123
Contact: Joseph Ojile    +001 (314) 645-6005    ojilej@claytonsleep.com   
United States, Nevada
Jubilee Clinical Research, Inc Active, not recruiting
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Shore Pulmonary, PA Active, not recruiting
Ocean City, New Jersey, United States, 07712
United States, New York
Bassett Medical Center Recruiting
Cooperstown, New York, United States, 13326
Contact: Lee Edmonds    +001 (607) 547-3283    lee.edmonds@bassett.org   
Pulmonary Health Physicians Active, not recruiting
Fayetteville, New York, United States, 13066
Feinstein Institute for Medical Research Recruiting
New Hyde Park, New York, United States, 11040
Contact: Jonathan Ilowite    +001 (516) 465-5400    jilowite@northwell.edu   
Lenox Hill Hospital Active, not recruiting
New York, New York, United States, 10021
Orchard Park Family Practice Recruiting
Orchard Park, New York, United States, 14127
Contact: Richard Ruh    +001 (716) 249-6700    RRuh@circuitclinical.com   
United States, North Carolina
Clinical Research of Gastonia Active, not recruiting
Gastonia, North Carolina, United States, 28054
Monroe Biomedical Research Recruiting
Monroe, North Carolina, United States, 28112
Contact: David Smith    +001 (704) 283-7359    david.smith@monroeresearch.com   
Coastal Carolina Health Care, P.A. Active, not recruiting
New Bern, North Carolina, United States, 28562
Tabor City Family Medicine Active, not recruiting
Tabor City, North Carolina, United States, 28463
Goshen Medical Center Active, not recruiting
Whiteville, North Carolina, United States, 28472
Southeastern Research Center Active, not recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Catherine LaRuffa, MD, Inc. Active, not recruiting
Blanchester, Ohio, United States, 45107
Valley Medical Primary Care Active, not recruiting
Centerville, Ohio, United States, 45459
Dayton Clinical Research Recruiting
Dayton, Ohio, United States, 45309
Contact: Martin Schear    +001 (937) 609-3677    mschear@aol.com   
Advance Clinical Research Recruiting
Dayton, Ohio, United States, 45417
Contact: Ugo Nwokoro    +001 (937) 716-1775    ugo.nwokoro@advanceclinicalresearch.com   
Midwest Pulmonary and Sleep Research Active, not recruiting
Dayton, Ohio, United States, 45459
Ohio Sleep and Pulmonary Center Active, not recruiting
Englewood, Ohio, United States, 45322
Prestige Clinical Research Active, not recruiting
Franklin, Ohio, United States, 45005
Robert Santiago MD, Inc. Active, not recruiting
Galion, Ohio, United States, 44833
Pulmonary, Critical Care and Sleep Medicine Associates Active, not recruiting
Hamilton, Ohio, United States, 45013
Wells Inst for Hlth Awareness Active, not recruiting
Kettering, Ohio, United States, 45429
Pulmonary Medicine Completed
South Euclid, Ohio, United States, 44121
Toledo Clinic Incorporated Active, not recruiting
Toledo, Ohio, United States, 43623
Ohio Clinical Research, LLC Completed
Willoughby Hills, Ohio, United States, 44094
Comprehensive Internal Medicine, Inc. Active, not recruiting
Wooster, Ohio, United States, 44691
United States, Pennsylvania
Preferred Primary Care Phys Recruiting
Pittsburgh, Pennsylvania, United States, 15236
Contact: Bryce Palchick    +001 (412) 650-6155    bpalchick@ppcp.org   
Preferred Primary Care Phys Recruiting
Pittsburgh, Pennsylvania, United States, 15243
Contact: Barry Austin    +001 (412) 942-0023    baustin@ppcp.org   
Frontier Clinical Research, LLC Recruiting
Scottdale, Pennsylvania, United States, 15683
Contact: Tiffany Pluto    +001 (724) 220-5281    tpluto@frontierclinical.com   
Frontier Clinical Research LLC Recruiting
Smithfield, Pennsylvania, United States, 15478
Contact: Marcy Goisse    +001 (724) 569-8100    mgoisseresearch@yahoo.com   
Preferred Primary Care Phys Recruiting
Uniontown, Pennsylvania, United States, 15401
Contact: Paul Hartley    +001 (724) 912-0033    phartley@ppcp.org   
Preferred Primary Care Phys Recruiting
Uniontown, Pennsylvania, United States, 15401
Contact: Joseph Labuda    +001 (724) 438-1479    jlabuda@ppcp.org   
United States, Rhode Island
BTC of Lincoln, LLC Recruiting
Lincoln, Rhode Island, United States, 02865
Contact: Syed Hussain    +001 (401) 333-3435    SHussain@BTCSites.com   
United States, South Carolina
Carolina Medical Research Active, not recruiting
Clinton, South Carolina, United States, 29325
Main Street Physicians Care Active, not recruiting
Little River, South Carolina, United States, 29566
Family Medicine of SayeBrook Active, not recruiting
Myrtle Beach, South Carolina, United States, 29588
United States, Tennessee
Holston Medical Group Recruiting
Bristol, Tennessee, United States, 37620
Contact: Andrew Brockmyre    +001 (423) 999-2415    andrew.brockmyre@myhmg.com   
United States, Texas
Pioneer Research Solutions, Inc. Recruiting
Beaumont, Texas, United States, 77702
Contact: Mohammad Aziz    +001 (713) 333-9323    maziz@pioneerresearchsolutions.com   
Houston Pulmonary Sleep Allergy and Asthma Associates Recruiting
Cypress, Texas, United States, 77429
Contact: Dileep Puppala    +001 (281) 955-0338    dileep.puppala@aceclinicalresearch.com   
North Texas Lung & Sleep Clnc Active, not recruiting
Fort Worth, Texas, United States, 76109
SMS Clinical Research Active, not recruiting
Mesquite, Texas, United States, 75149
Texarkana Clinical Research Active, not recruiting
Texarkana, Texas, United States, 75503
United States, Utah
Wasatch Clinical Research Recruiting
Salt Lake City, Utah, United States, 84107
Contact: Michael Killpack    +001 (801) 288-0607    mkillpack@wasatchcrc.com   
United States, Virginia
Chesapeake Pulmonary and Critical Care Active, not recruiting
Chesapeake, Virginia, United States, 23320
Richmond Family Practice Active, not recruiting
Richmond, Virginia, United States, 23220
United States, Washington
Western Washington Medical Grp Active, not recruiting
Everett, Washington, United States, 98208
United States, Wisconsin
Pulmonary and Critical Care Associates, SC Active, not recruiting
Cudahy, Wisconsin, United States, 53110
Sponsors and Collaborators
Boehringer Ingelheim
Healthcore

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03265145     History of Changes
Other Study ID Numbers: 1237-0064
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Muscarinic Antagonists
Tiotropium Bromide
Olodaterol
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics