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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Effectiveness and Safety of Maintenance Treatment With Combination of Tiotropium and Olodaterol in Comparison to Maintenance Treatment With a Combination of Inhaled Corticosteroids, Long-acting β2 Agonists and Long-acting Muscarinic Antagonists in COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04184297
• Other study ID #: 1237-0094
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: November 4, 2019

Study information

• Verified date: November 2021
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27190
• Est. completion date: November 4, 2019
• Est. primary completion date: November 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium and Olodaterol (Tio+Olo)
drug
• Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS)
drug

Locations

Country	Name	City	State
United States	HealthCore, Inc.	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Overall Incidence Rate of Hospitalization for Community-acquired Pneumonia (Serious Pneumonia)	Overall incidence rate of first 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.

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