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Completed

NCT Number: NCT03265145

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]

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pulmonary Associates of Mobile, PC, Mobile, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stiolto Respimat

Drug

Duration - 12 months

Other names: INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Carelon Research

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 29, 2017
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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