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]
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Drug: ICS (Inhaled Corticosteroid) (Triple therapy)Drug: LABA (Long-Acting Beta Agonist) (Triple therapy)Drug: LAMA (Long-Acting Muscarinic Antagonist) (Triple therapy)
- Registration Number
- NCT03265145
- Lead Sponsor
- Boehringer Ingelheim
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 714
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ICS plus LABA plus LAMA (triple therapy) ICS (Inhaled Corticosteroid) (Triple therapy) ICS (Inhaled Corticosteroid) plus LABA (Long-Acting Beta Agonist) plus (Long-Acting Muscarinic Antagonist) Stiolto Respimat Stiolto Respimat - ICS plus LABA plus LAMA (triple therapy) LAMA (Long-Acting Muscarinic Antagonist) (Triple therapy) ICS (Inhaled Corticosteroid) plus LABA (Long-Acting Beta Agonist) plus (Long-Acting Muscarinic Antagonist) ICS plus LABA plus LAMA (triple therapy) LABA (Long-Acting Beta Agonist) (Triple therapy) ICS (Inhaled Corticosteroid) plus LABA (Long-Acting Beta Agonist) plus (Long-Acting Muscarinic Antagonist)
- Primary Outcome Measures
Name Time Method Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the 12 Month Study Period 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 Outcome Measures
Name Time Method Time to First Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over 12 Months of Treatment Pulmonary Disease 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 Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations 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.Annual Rate of Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations 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 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).
Trial Locations
- Locations (86)
Pulmonary Associates of Mobile, PC
🇺🇸Mobile, Alabama, United States
Healthscan Clinical Trials LLC
🇺🇸Montgomery, Alabama, United States
HealthScan Research
🇺🇸Montgomery, Alabama, United States
Diamond Childrens Medical Center
🇺🇸Tucson, Arizona, United States
CareMore Apple Valley Care Center
🇺🇸Apple Valley, California, United States
HealthCare Partners
🇺🇸Commerce, California, United States
Advanced Research Center, Inc.
🇺🇸Murrieta, California, United States
Newport Native MD, Inc
🇺🇸Newport Beach, California, United States
Aureus Medical Group, Inc
🇺🇸Rancho Cucamonga, California, United States
Capital Allergy and Respiratory Disease Center
🇺🇸Roseville, California, United States
Scroll for more (76 remaining)Pulmonary Associates of Mobile, PC🇺🇸Mobile, Alabama, United States