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]

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Randomized Pragmatic Clinical Trial in a Community-Based Setting Comparing STIOLTO® RESPIMAT® vs. ICS-LABA Plus LAMA in Patients With COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265145
• Other study ID #: 1237-0064
• Status: Completed
• Phase: Phase 4
• Start date: September 20, 2017
• Est. completion date: September 30, 2020

Study information

• Verified date: May 2022
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 714
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Stiolto Respimat
Duration - 12 months
• ICS (Inhaled Corticosteroid) (Triple therapy)
Duration - 12 months
• LABA (Long-Acting Beta Agonist) (Triple therapy)
Duration - 12 months
• LAMA (Long-Acting Muscarinic Antagonist) (Triple therapy)
Duration - 12 months

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	HealthCore-NERI

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.

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