Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to Triple Therapy

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Tiotropium and Olodaterol (Tio+Olo); Drug: Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS)

• Registration Number: NCT04184297
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To assess the comparative effectiveness of combination Tiotropium and Olodaterol (Tio+Olo) (FDC) compared to combination LAMA/LABA and ICS (fixed or open), and to explore whether this varies across COPD sub populations defined by exacerbation risk

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-11-01
• Primary Completion: 2019-11-04
• Study Completion: 2019-11-04
• Study First Submitted: 2019-11-28
• Study First Submitted QC: 2019-11-28
• Study First Posted: 2019-12-03
• Results First Submitted: 2020-10-28
• Results First Submitted QC: 2020-11-26
• Results First Posted: 2020-11-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-12
• Last Update Posted: 2021-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27190

Inclusion Criteria

• New users of Tio+Olo on the same date or of LABA, LAMA and ICS, either as a fixed-dose combination (LABA/LAMA/ICS) or free combination (LABA/ICS + LAMA, etc), on the same date between January 2013 and March 2019.
• Diagnosis of COPD prior to first maintenance inhaler and age ≥ 40 years at index date

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Exclusion Criteria

• Less than one year of medical history information prior to the date of combined treatment initiation (index date)
• Lung cancer, interstitial lung disease, or lung transplantation at any time prior to the index date
• Asthma diagnosis within one year prior to the index date

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects initiated with Tiotropium and Olodaterol (Tio+Olo)	Tiotropium and Olodaterol (Tio+Olo)	-
Subjets initiated with LABA/LAMA/ICS	Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS)	Long-acting beta2/ Long-acting muscarinic antagonists/Inhaled corticosteriods

Primary Outcome Measures

Name	Time	Method
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation	From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry.	Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation was reported. Time to the first Chronic obstructive pulmonary disease (COPD) exacerbation will be measured from cohort entry until the occurrence of a hospitalization for COPD (severe exacerbation) or Emergency Department (ED) visit for COPD with the prescription of an antibiotic and/or an oral corticosteroid on the same day (moderate exacerbation).
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation - Without Exacerbation Within 30 Days Prior to Cohort Entry	From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry.	Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation excluding participants who had exacerbation within 30 days prior to cohort entry, was reported. Time to the first Chronic obstructive pulmonary disease (COPD) exacerbation will be measured from cohort entry until the occurrenceof a hospitalization for COPD (severe exacerbation) or Emergency Department (ED) visit for COPD with the prescription of an antibiotic and/or an oral corticosteroid on the same day (moderate exacerbation).

Secondary Outcome Measures

Name	Time	Method
Overall Incidence Rate of Hospitalization for Community-acquired Pneumonia (Serious Pneumonia)	From cohort entry (index date) until the occurrence of hospitalization for community-acquired pneumonia (serious pneumonia). Up to 1 year after cohort entry.	Overall incidence rate of first hospitalization for community-acquired pneumonia (serious pneumonia).

Trial Locations

Locations (1)

HealthCore, Inc.; 🇺🇸 Andover, Massachusetts, United States