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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]

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Stiolto Respimat
ICS (Inhaled Corticosteroid) (Triple therapy)
LABA (Long-Acting Beta Agonist) (Triple therapy)
LAMA (Long-Acting Muscarinic Antagonist) (Triple therapy)
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pulmonary Associates of Mobile, PC
  • Healthscan Clinical Trials LLC
  • HealthScan Research
  • Diamond Childrens Medical Center
  • CareMore Apple Valley Care Center
  • HealthCare Partners
  • Advanced Research Center, Inc.
  • Newport Native MD, Inc
  • Aureus Medical Group, Inc
  • Capital Allergy and Respiratory Disease Center
  • Paloma Medical Group
  • Adnab Research/Prestige Care Physician
  • Pulmonary and Sleep of Tampa Bay
  • Innovative Research of West Florida, Inc.
  • Saint Francis Sleep, Allergy and Lung Institute, LLC
  • Cohen Medical Research Associates, LLC
  • Gary J. Richmond, M.D., PA
  • Medical Research of Central Florida
  • Florida Lung and Sleep Associates
  • TRY Research
  • Pro Live Medical Research
  • Advanced Research for Health Improvement, LLC
  • Oviedo Medical Research
  • Pasadena Ctr for Medical Rsrch
  • Bassetti Medical Research Inc
  • John Suen MD PA
  • Gwinnett Research Institute
  • Pulmonary and Sleep Specialists, PC
  • DC Pulmonary Medicine
  • Southern IL Clinical Rsrch Ctr
  • American Health Network of Indiana, LLC
  • American Health Network of Indiana, LLC
  • The LaPorte County Institute for Clinical Research
  • Ball Memorial Hospital
  • American Health Network
  • Kentucky Lung Clinic
  • Pulmonary and Sleep Clinic PLLV
  • Johns Hopkins Hospital
  • Pulmonary and Critical Care Associates of Baltimore
  • Pulmonary and Critical Care Associates of Baltimore
  • Lahey Hospital and Medical Center
  • Vida Clinical Studies
  • Flint Clinical Research
  • Clayton Sleep Institute
  • Mercy Surgery Center
  • Jubilee Clinical Research, Inc
  • Shore Pulmonary, PA
  • Bassett Medical Center
  • Pulmonary Health Physicians
  • Feinstein Institute for Medical Research
  • Lenox Hill Hospital
  • Orchard Park Family Practice
  • American Health Research, Inc.
  • Clinical Research of Gastonia
  • Coastal Carolina Health Care, P.A.
  • Tabor City Family Medicine
  • Goshen Medical Center
  • Southeastern Research Center
  • Catherine LaRuffa, MD, Inc.
  • Valley Medical Primary Care
  • University Hospitals of Cleveland
  • Midwest Pulmonary and Sleep Research
  • Ohio Sleep and Pulmonary Center
  • Prestige Clinical Research
  • Robert Santiago MD, Inc.
  • Pulmonary, Critical Care and Sleep Medicine Associates
  • Wells Inst for Hlth Awareness
  • Pulmonary Medicine
  • Toledo Clinic Incorporated
  • Ohio Clinical Research, LLC
  • Comprehensive Internal Medicine, Inc.
  • Preferred Primary Care Phys
  • Preferred Primary Care Phys
  • Frontier Clinical Research, LLC
  • Frontier Clinical Research LLC
  • Preferred Primary Care Phys
  • Carolina Medical Research
  • Main Street Physicians Care
  • Family Medicine of SayeBrook
  • Houston Pulmonary Sleep Allergy and Asthma Associates
  • Texas Health Physicians Group
  • North Texas Lung & Sleep Clnc
  • SMS Clinical Research
  • San Marcos Family Medicine
  • Texarkana Clinical Research
  • Chesapeake Pulmonary and Critical Care
  • Richmond Family Practice
  • MultiCare Institute
  • Western Washington Medical Grp
  • Pulmonary and Critical Care Associates, SC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stiolto Respimat

ICS plus LABA plus LAMA (triple therapy)

Arm Description

ICS (Inhaled Corticosteroid) plus LABA (Long-Acting Beta Agonist) plus (Long-Acting Muscarinic Antagonist)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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).

Full Information

First Posted
August 25, 2017
Last Updated
May 24, 2022
Sponsor
Boehringer Ingelheim
Collaborators
Carelon Research
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1. Study Identification

Unique Protocol Identification Number
NCT03265145
Brief Title
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]
Official Title
Randomized Pragmatic Clinical Trial in a Community-Based Setting Comparing STIOLTO® RESPIMAT® vs. ICS-LABA Plus LAMA in Patients With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 20, 2017 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
Collaborators
Carelon Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: To compare the annual rate of moderate or severe COPD exacerbations for patients on Stiolto Respimat with patients on triple therapy. To compare the time to first severe COPD exacerbation in both treatment arms. To compare the annual rate of severe COPD exacerbations in both treatment arms. To compare the proportion of patients with moderate or severe COPD exacerbations in both treatment arms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
714 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stiolto Respimat
Arm Type
Experimental
Arm Title
ICS plus LABA plus LAMA (triple therapy)
Arm Type
Active Comparator
Arm Description
ICS (Inhaled Corticosteroid) plus LABA (Long-Acting Beta Agonist) plus (Long-Acting Muscarinic Antagonist)
Intervention Type
Drug
Intervention Name(s)
Stiolto Respimat
Other Intervention Name(s)
INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO
Intervention Description
Duration - 12 months
Intervention Type
Drug
Intervention Name(s)
ICS (Inhaled Corticosteroid) (Triple therapy)
Intervention Description
Duration - 12 months
Intervention Type
Drug
Intervention Name(s)
LABA (Long-Acting Beta Agonist) (Triple therapy)
Intervention Description
Duration - 12 months
Intervention Type
Drug
Intervention Name(s)
LAMA (Long-Acting Muscarinic Antagonist) (Triple therapy)
Intervention Description
Duration - 12 months
Primary Outcome Measure Information:
Title
Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the 12 Month Study Period
Description
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.
Time Frame
Baseline till end of study, up to 12 months.
Secondary Outcome Measure Information:
Title
Annual Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Description
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.
Time Frame
Baseline till end of study, up to 12 months.
Title
Time to First Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over 12 Months of Treatment Pulmonary Disease
Description
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.
Time Frame
Baseline till end of study, up to 12 months.
Title
Annual Rate of Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Description
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.
Time Frame
Baseline till end of study, up to 12 months.
Title
Number of Patients With Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Over the 12 Month Observation Period
Description
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).
Time Frame
12 months after baseline.

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.mystudywindow.com/msw/datasharing
Links:
URL
https://www.mystudywindow.com
Description
Related Info

Learn more about this trial

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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