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]
Public ClinicalTrials.gov record NCT03265145. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized Pragmatic Clinical Trial in a Community-Based Setting Comparing STIOLTO® RESPIMAT® vs. ICS-LABA Plus LAMA in Patients With COPD
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03265145
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 714 participants
Conditions and interventions
Conditions
Interventions
- Stiolto Respimat Drug
- ICS (Inhaled Corticosteroid) (Triple therapy) Drug
- LABA (Long-Acting Beta Agonist) (Triple therapy) Drug
- LAMA (Long-Acting Muscarinic Antagonist) (Triple therapy) Drug
Drug
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 20, 2017 (Actual)
- Primary completion
- Sep 30, 2020 (Actual)
- Completion
- Sep 30, 2020 (Actual)
- Last update posted
- Jun 14, 2022
2017 – 2020
United States locations
- U.S. sites
- 90
- U.S. states
- 23
- U.S. cities
- 87
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pulmonary Associates of Mobile, PC | Mobile | Alabama | 36608 | — |
| Healthscan Clinical Trials LLC | Montgomery | Alabama | 36106 | — |
| HealthScan Research | Montgomery | Alabama | 36109 | — |
| Diamond Childrens Medical Center | Tucson | Arizona | 85724 | — |
| CareMore Apple Valley Care Center | Apple Valley | California | 92308 | — |
| HealthCare Partners | Commerce | California | 90040 | — |
| Advanced Research Center, Inc. | Murrieta | California | 92562 | — |
| Newport Native MD, Inc | Newport Beach | California | 92663 | — |
| Aureus Medical Group, Inc | Rancho Cucamonga | California | 91730 | — |
| Capital Allergy and Respiratory Disease Center | Roseville | California | 95661 | — |
| Paloma Medical Group | San Juan Capistrano | California | 92675 | — |
| Adnab Research/Prestige Care Physician | Torrance | California | 90505 | — |
| Pulmonary and Sleep of Tampa Bay | Brandon | Florida | 33511 | — |
| Innovative Research of West Florida, Inc. | Clearwater | Florida | 33756 | — |
| Saint Francis Sleep, Allergy and Lung Institute, LLC | Clearwater | Florida | 33765 | — |
| Cohen Medical Research Associates, LLC | Delray Beach | Florida | 33446 | — |
| Gary J. Richmond, M.D., PA | Fort Lauderdale | Florida | 33316 | — |
| Medical Research of Central Florida | Leesburg | Florida | 34748 | — |
| Florida Lung and Sleep Associates | Lehigh Acres | Florida | 33971 | — |
| TRY Research | Maitland | Florida | 32751 | — |
| Pro Live Medical Research | Miami | Florida | 33175 | — |
| Advanced Research for Health Improvement, LLC | Naples | Florida | 34102 | — |
| Oviedo Medical Research | Oviedo | Florida | 32765 | — |
| Bassetti Medical Research Inc | Sebring | Florida | 33870 | — |
| Pasadena Ctr for Medical Rsrch | St. Petersburg | Florida | 33707 | — |
| John Suen MD PA | Vero Beach | Florida | 32960 | — |
| Gwinnett Research Institute | Buford | Georgia | 30519 | — |
| Pulmonary and Sleep Specialists, PC | Decatur | Georgia | 30033 | — |
| DC Pulmonary Medicine | Marietta | Georgia | 30060 | — |
| Southern IL Clinical Rsrch Ctr | O'Fallon | Illinois | 62269 | — |
| American Health Network of Indiana, LLC | Franklin | Indiana | 46131 | — |
| American Health Network of Indiana, LLC | Greenfield | Indiana | 46140 | — |
| The LaPorte County Institute for Clinical Research | Michigan City | Indiana | 46360 | — |
| Ball Memorial Hospital | Muncie | Indiana | 47303 | — |
| American Health Network | New Albany | Indiana | 47150 | — |
| Kentucky Lung Clinic | Georgetown | Kentucky | 40324 | — |
| Pulmonary and Sleep Clinic PLLV | Hopkinsville | Kentucky | 42240 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21224 | — |
| Pulmonary and Critical Care Associates of Baltimore | Bel Air | Maryland | 21014 | — |
| Pulmonary and Critical Care Associates of Baltimore | Towson | Maryland | 21286 | — |
| Lahey Hospital and Medical Center | Burlington | Massachusetts | 01805 | — |
| Vida Clinical Studies | Dearborn | Michigan | 48124 | — |
| Flint Clinical Research | Flint | Michigan | 48503 | — |
| Mercy Surgery Center | Springfield | Missouri | 65804 | — |
| Clayton Sleep Institute | St Louis | Missouri | 63123 | — |
| Jubilee Clinical Research, Inc | Las Vegas | Nevada | 89106 | — |
| Shore Pulmonary, PA | Ocean City | New Jersey | 07712 | — |
| Bassett Medical Center | Cooperstown | New York | 13326 | — |
| Pulmonary Health Physicians | Fayetteville | New York | 13066 | — |
| Feinstein Institute for Medical Research | New Hyde Park | New York | 11040 | — |
| Lenox Hill Hospital | New York | New York | 10021 | — |
| Orchard Park Family Practice | Orchard Park | New York | 14127 | — |
| American Health Research, Inc. | Charlotte | North Carolina | 28207 | — |
| Clinical Research of Gastonia | Gastonia | North Carolina | 28054 | — |
| Coastal Carolina Health Care, P.A. | New Bern | North Carolina | 28562 | — |
| Tabor City Family Medicine | Tabor City | North Carolina | 28463 | — |
| Goshen Medical Center | Whiteville | North Carolina | 28472 | — |
| Southeastern Research Center | Winston-Salem | North Carolina | 27103 | — |
| Catherine LaRuffa, MD, Inc. | Blanchester | Ohio | 45107 | — |
| Valley Medical Primary Care | Centerville | Ohio | 45459 | — |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | — |
| Midwest Pulmonary and Sleep Research | Dayton | Ohio | 45459 | — |
| Ohio Sleep and Pulmonary Center | Englewood | Ohio | 45322 | — |
| Prestige Clinical Research | Franklin | Ohio | 45005 | — |
| Robert Santiago MD, Inc. | Galion | Ohio | 44833 | — |
| Pulmonary, Critical Care and Sleep Medicine Associates | Hamilton | Ohio | 45013 | — |
| Wells Inst for Hlth Awareness | Kettering | Ohio | 45429 | — |
| Pulmonary Medicine | South Euclid | Ohio | 44121 | — |
| Toledo Clinic Incorporated | Toledo | Ohio | 43623 | — |
| Ohio Clinical Research, LLC | Willoughby Hills | Ohio | 44094 | — |
| Comprehensive Internal Medicine, Inc. | Wooster | Ohio | 44691 | — |
| Preferred Primary Care Phys | Pittsburgh | Pennsylvania | 15236 | — |
| Preferred Primary Care Phys | Pittsburgh | Pennsylvania | 15243 | — |
| Frontier Clinical Research, LLC | Scottdale | Pennsylvania | 15683 | — |
| Frontier Clinical Research LLC | Smithfield | Pennsylvania | 15478 | — |
| Preferred Primary Care Phys | Uniontown | Pennsylvania | 15401 | — |
| Carolina Medical Research | Clinton | South Carolina | 29325 | — |
| Main Street Physicians Care | Little River | South Carolina | 29566 | — |
| Family Medicine of SayeBrook | Myrtle Beach | South Carolina | 29588 | — |
| Houston Pulmonary Sleep Allergy and Asthma Associates | Cypress | Texas | 77429 | — |
| Texas Health Physicians Group | Dallas | Texas | 75243 | — |
| North Texas Lung & Sleep Clnc | Fort Worth | Texas | 76109 | — |
| SMS Clinical Research | Mesquite | Texas | 75149 | — |
| San Marcos Family Medicine | San Marcos | Texas | 78666 | — |
| Texarkana Clinical Research | Texarkana | Texas | 75503 | — |
| Chesapeake Pulmonary and Critical Care | Chesapeake | Virginia | 23320 | — |
| Richmond Family Practice | Richmond | Virginia | 23220 | — |
| MultiCare Institute | Cheney | Washington | 99004 | — |
| Western Washington Medical Grp | Everett | Washington | 98208 | — |
| Pulmonary and Critical Care Associates, SC | Cudahy | Wisconsin | 53110 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03265145, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 14, 2022 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03265145 live on ClinicalTrials.gov.