Skip to main content
OpenTrials
Completed

NCT Number: NCT04184297

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

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

Completed

Looking for future studies?

Notify Me

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

Observational

Primary location

HealthCore, Inc.

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Tiotropium and Olodaterol (Tio+Olo)

Drug

drug

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

Drug

drug

Primary outcomes

  1. Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

    Time frame: 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).

  2. Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation - Without Exacerbation Within 30 Days Prior to Cohort Entry

    Time frame: 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 outcomes

  1. Overall Incidence Rate of Hospitalization for Community-acquired Pneumonia (Serious Pneumonia)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 3, 2019
Registry last updated
Nov 15, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.