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

NCT04184297 | Completed Results FDA Drug

• 1 other identifier: 1237-0094
• Study Type: observational
• Target: 27,190
• Locations: 1 country
• Sites: 1

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

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

• Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

  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).

  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 - Without Exacerbation Within 30 Days Prior to 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).

  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.

Secondary Outcomes (1)

• 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.

Study Arms (2)

Subjects initiated with Tiotropium and Olodaterol (Tio+Olo)

Drug: Tiotropium and Olodaterol (Tio+Olo)

Subjets initiated with LABA/LAMA/ICS

Long-acting beta2/ Long-acting muscarinic antagonists/Inhaled corticosteriods

Drug: Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS)

Interventions

Tiotropium and Olodaterol (Tio+Olo) DRUG

drug

Subjects initiated with Tiotropium and Olodaterol (Tio+Olo)

Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS) DRUG

drug

Subjets initiated with LABA/LAMA/ICS

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with COPD inititated with Tio+Olo in comparison to patients treated with ICS/LABA/LAMA

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

HealthCore, Inc.

Andover, Massachusetts, 01810, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide; olodaterol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 3, 2019
• Study Start: November 1, 2019
• Primary Completion: November 4, 2019
• Study Completion: November 4, 2019
• Last Updated: November 15, 2021
• Results First Posted: November 30, 2020

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)