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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 : Completed
First Posted : August 29, 2017
Results First Posted : December 9, 2021
Last Update Posted : June 14, 2022
Sponsor:
Collaborator:
HealthCore-NERI
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE August 25, 2017
First Posted Date  ICMJE August 29, 2017
Results First Submitted Date  ICMJE September 29, 2021
Results First Posted Date  ICMJE December 9, 2021
Last Update Posted Date June 14, 2022
Actual Study Start Date  ICMJE September 20, 2017
Actual Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2021)
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. ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 25, 2017)
Time to first moderate or severe chronic obstructive pulmonary disease (COPD) exacerbation [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2021)
  • Annual Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations [ Time Frame: Baseline till end of study, up to 12 months. ]
    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 Frame: Baseline till end of study, up to 12 months. ]
    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 [ Time Frame: Baseline till end of study, up to 12 months. ]
    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 [ Time Frame: 12 months after baseline. ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2017)
  • Annual rate of moderate or severe chronic obstructive pulmonary disease (COPD) exacerbations [ Time Frame: 12 months ]
  • Time to first severe chronic obstructive pulmonary disease (COPD) exacerbation [ Time Frame: 12 months ]
  • Annual rate of severe chronic obstructive pulmonary disease (COPD) exacerbations [ Time Frame: 12 months ]
  • Proportion of patients with moderate or severe chronic obstructive pulmonary disease (COPD) exacerbations [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE Randomized Pragmatic Clinical Trial in a Community-Based Setting Comparing STIOLTO® RESPIMAT® vs. ICS-LABA Plus LAMA in Patients With COPD
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE
  • Drug: Stiolto Respimat
    Duration - 12 months
    Other Name: INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO
  • 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
Study Arms  ICMJE
  • Experimental: Stiolto Respimat
    Intervention: Drug: Stiolto Respimat
  • Active Comparator: ICS plus LABA plus LAMA (triple therapy)
    ICS (Inhaled Corticosteroid) plus LABA (Long-Acting Beta Agonist) plus (Long-Acting Muscarinic Antagonist)
    Interventions:
    • Drug: ICS (Inhaled Corticosteroid) (Triple therapy)
    • Drug: LABA (Long-Acting Beta Agonist) (Triple therapy)
    • Drug: LAMA (Long-Acting Muscarinic Antagonist) (Triple therapy)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 12, 2021)
714
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2017)
3200
Actual Study Completion Date  ICMJE September 30, 2020
Actual Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03265145
Other Study ID Numbers  ICMJE 1237-0064
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.

Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
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.
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.
URL: https://www.mystudywindow.com/msw/datasharing
Current Responsible Party Boehringer Ingelheim
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Boehringer Ingelheim
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE HealthCore-NERI
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP