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Pulmonary Disease, Chronic ObstructivePhase 4NCT03265145

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]

A Phase 4 study testing Stiolto Respimat, ICS (Inhaled Corticosteroid) (Triple therapy) and LABA (Long-Acting Beta Agonist) (Triple therapy) in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 90 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Stiolto Respimat, ICS (Inhaled Corticosteroid) (Triple therapy) and LABA (Long-Acting Beta Agonist) (Triple therapy)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
714 participants
Where
90 sitesUnited States
Study dates
20 Sep 2017to 30 Sep 2020
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

90 sites in 1 country.

90 sites in 1 country

United States90 sites

  • CareMore Apple Valley Care Center

    Apple Valley, California, 92308

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21224

  • Pulmonary and Critical Care Associates of Baltimore

    Bel Air, Maryland, 21014

  • Catherine LaRuffa, MD, Inc.

    Blanchester, Ohio, 45107

  • Pulmonary and Sleep of Tampa Bay

    Brandon, Florida, 33511

  • Gwinnett Research Institute

    Buford, Georgia, 30519

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • Valley Medical Primary Care

    Centerville, Ohio, 45459

  • American Health Research, Inc.

    Charlotte, North Carolina, 28207

  • MultiCare Institute

    Cheney, Washington, 99004

  • Chesapeake Pulmonary and Critical Care

    Chesapeake, Virginia, 23320

  • Innovative Research of West Florida, Inc.

    Clearwater, Florida, 33756

  • Saint Francis Sleep, Allergy and Lung Institute, LLC

    Clearwater, Florida, 33765

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Carolina Medical Research

    Clinton, South Carolina, 29325

  • HealthCare Partners

    Commerce, California, 90040

  • Bassett Medical Center

    Cooperstown, New York, 13326

  • Pulmonary and Critical Care Associates, SC

    Cudahy, Wisconsin, 53110

  • Houston Pulmonary Sleep Allergy and Asthma Associates

    Cypress, Texas, 77429

  • Texas Health Physicians Group

    Dallas, Texas, 75243

  • Midwest Pulmonary and Sleep Research

    Dayton, Ohio, 45459

  • Vida Clinical Studies

    Dearborn, Michigan, 48124

  • Pulmonary and Sleep Specialists, PC

    Decatur, Georgia, 30033

  • Cohen Medical Research Associates, LLC

    Delray Beach, Florida, 33446

  • Ohio Sleep and Pulmonary Center

    Englewood, Ohio, 45322

  • Western Washington Medical Grp

    Everett, Washington, 98208

  • Pulmonary Health Physicians

    Fayetteville, New York, 13066

  • Flint Clinical Research

    Flint, Michigan, 48503

  • Gary J. Richmond, M.D., PA

    Fort Lauderdale, Florida, 33316

  • North Texas Lung & Sleep Clnc

    Fort Worth, Texas, 76109

  • American Health Network of Indiana, LLC

    Franklin, Indiana, 46131

  • Prestige Clinical Research

    Franklin, Ohio, 45005

  • Robert Santiago MD, Inc.

    Galion, Ohio, 44833

  • Clinical Research of Gastonia

    Gastonia, North Carolina, 28054

  • Kentucky Lung Clinic

    Georgetown, Kentucky, 40324

  • American Health Network of Indiana, LLC

    Greenfield, Indiana, 46140

  • Pulmonary, Critical Care and Sleep Medicine Associates

    Hamilton, Ohio, 45013

  • Pulmonary and Sleep Clinic PLLV

    Hopkinsville, Kentucky, 42240

  • Wells Inst for Hlth Awareness

    Kettering, Ohio, 45429

  • Jubilee Clinical Research, Inc

    Las Vegas, Nevada, 89106

  • Medical Research of Central Florida

    Leesburg, Florida, 34748

  • Florida Lung and Sleep Associates

    Lehigh Acres, Florida, 33971

  • Main Street Physicians Care

    Little River, South Carolina, 29566

  • TRY Research

    Maitland, Florida, 32751

  • DC Pulmonary Medicine

    Marietta, Georgia, 30060

  • SMS Clinical Research

    Mesquite, Texas, 75149

  • Pro Live Medical Research

    Miami, Florida, 33175

  • The LaPorte County Institute for Clinical Research

    Michigan City, Indiana, 46360

  • Pulmonary Associates of Mobile, PC

    Mobile, Alabama, 36608

  • Healthscan Clinical Trials LLC

    Montgomery, Alabama, 36106

  • HealthScan Research

    Montgomery, Alabama, 36109

  • Ball Memorial Hospital

    Muncie, Indiana, 47303

  • Advanced Research Center, Inc.

    Murrieta, California, 92562

  • Family Medicine of SayeBrook

    Myrtle Beach, South Carolina, 29588

  • Advanced Research for Health Improvement, LLC

    Naples, Florida, 34102

  • American Health Network

    New Albany, Indiana, 47150

  • Coastal Carolina Health Care, P.A.

    New Bern, North Carolina, 28562

  • Feinstein Institute for Medical Research

    New Hyde Park, New York, 11040

  • Lenox Hill Hospital

    New York, New York, 10021

  • Newport Native MD, Inc

    Newport Beach, California, 92663

  • Southern IL Clinical Rsrch Ctr

    O'Fallon, Illinois, 62269

  • Shore Pulmonary, PA

    Ocean City, New Jersey, 07712

  • Orchard Park Family Practice

    Orchard Park, New York, 14127

  • Oviedo Medical Research

    Oviedo, Florida, 32765

  • Preferred Primary Care Phys

    Pittsburgh, Pennsylvania, 15236

  • Preferred Primary Care Phys

    Pittsburgh, Pennsylvania, 15243

  • Aureus Medical Group, Inc

    Rancho Cucamonga, California, 91730

  • Richmond Family Practice

    Richmond, Virginia, 23220

  • Capital Allergy and Respiratory Disease Center

    Roseville, California, 95661

  • Paloma Medical Group

    San Juan Capistrano, California, 92675

  • San Marcos Family Medicine

    San Marcos, Texas, 78666

  • Frontier Clinical Research, LLC

    Scottdale, Pennsylvania, 15683

  • Bassetti Medical Research Inc

    Sebring, Florida, 33870

  • Frontier Clinical Research LLC

    Smithfield, Pennsylvania, 15478

  • Pulmonary Medicine

    South Euclid, Ohio, 44121

  • Mercy Surgery Center

    Springfield, Missouri, 65804

  • Clayton Sleep Institute

    St Louis, Missouri, 63123

  • Pasadena Ctr for Medical Rsrch

    St. Petersburg, Florida, 33707

  • Tabor City Family Medicine

    Tabor City, North Carolina, 28463

  • Texarkana Clinical Research

    Texarkana, Texas, 75503

  • Toledo Clinic Incorporated

    Toledo, Ohio, 43623

  • Adnab Research/Prestige Care Physician

    Torrance, California, 90505

  • Pulmonary and Critical Care Associates of Baltimore

    Towson, Maryland, 21286

  • Diamond Childrens Medical Center

    Tucson, Arizona, 85724

  • Preferred Primary Care Phys

    Uniontown, Pennsylvania, 15401

  • John Suen MD PA

    Vero Beach, Florida, 32960

  • Goshen Medical Center

    Whiteville, North Carolina, 28472

  • Ohio Clinical Research, LLC

    Willoughby Hills, Ohio, 44094

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103

  • Comprehensive Internal Medicine, Inc.

    Wooster, Ohio, 44691

Other trials in United States

About this study

Official title: 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.
Being tested
Stiolto Respimat, ICS (Inhaled Corticosteroid) (Triple therapy), LABA (Long-Acting Beta Agonist) (Triple therapy), LAMA (Long-Acting Muscarinic Antagonist) (Triple therapy)
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stiolto RespimatDrug

    Also called INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO

    Duration - 12 months

  • ICS (Inhaled Corticosteroid) (Triple therapy)Drug

    Duration - 12 months

  • LABA (Long-Acting Beta Agonist) (Triple therapy)Drug

    Duration - 12 months

  • LAMA (Long-Acting Muscarinic Antagonist) (Triple therapy)Drug

    Duration - 12 months

Study groups in NCT03265145
Study groupRoleWhat they receive
Stiolto RespimatExperimentalNot described
Receives: Drug: Stiolto Respimat
ICS plus LABA plus LAMA (triple therapy)Active comparatorICS (Inhaled Corticosteroid) plus LABA (Long-Acting Beta Agonist) plus (Long-Acting Muscarinic Antagonist)
Receives: Drug: ICS (Inhaled Corticosteroid) (Triple therapy); Drug: LABA (Long-Acting Beta Agonist) (Triple therapy); Drug: LAMA (Long-Acting Muscarinic Antagonist) (Triple therapy)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline till end of study, up to 12 months.

Secondary outcomes (4)

  1. 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.

    Measured: Baseline till end of study, up to 12 months.

  2. 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.

    Measured: Baseline till end of study, up to 12 months.

  3. 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.

    Measured: Baseline till end of study, up to 12 months.

  4. 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).

    Measured: 12 months after baseline.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2017
  2. Study start20 Sep 2017
  3. Primary completion30 Sep 2020
  4. Study completion30 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
714 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03265145
Sponsor's protocol ID
1237-0064
Status last verified
May 2022
First submitted
25 Aug 2017
Last updated
14 Jun 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Stiolto Respimat, ICS (Inhaled Corticosteroid) (Triple therapy) and LABA (Long-Acting Beta Agonist) (Triple therapy) in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 90 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the 12 Month Study Period (time frame: Baseline till end of study, up to 12 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03265145.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.

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