Comparative Effectiveness of COPD Treatments

Overview

To assess the effectiveness of maintenance treatment of Chronic obstructive pulmonary disease (COPD) with the combination of a long-acting bronchodilators (LABA and the long-acting muscarinic antagonists (LAMA) tiotropium (LABA-TIO)) compared with the combination of a LABA and an ICS (LABA-ICS) on the time to COPD exacerbation.

Full Title of Study: “Comparative Effectiveness of Combination Therapies in COPD”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: December 31, 2017

Interventions

  • Drug: LABA and the LAMA tiotropium (LABA-TIO)
    • combinational drug
  • Drug: LABA and an ICS (LABA-ICS)
    • combinational drug

Arms, Groups and Cohorts

  • Subjects diagnosed with COPD
    • Chronic obstructive pulmonary disease

Clinical Trial Outcome Measures

Primary Measures

  • The Number of Observed Patients With First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation to Occur After Cohort Entry
    • Time Frame: 12 Years
    • The number of observed patients with first COPD exacerbation after cohort entry was reported. The event of time to first COPD exacerbation to occur after cohort entry was defined as a hospitalization for COPD (severe exacerbation) or the prescription of an oral corticosteroid, namely prednisolone (moderate exacerbation) to occur after cohort entry with one-year follow-up, from the as-treated analysis.

Secondary Measures

  • The Rate of COPD Exacerbations
    • Time Frame: 12 years
    • Incidence rates and rate ratios of the moderate or severe exacerbation associated with LABA-TIO relative to LABA-ICS in patients with COPD, with one-year follow-up, from the as-treated analysis, estimated.
  • The Occurrence of the First Hospitalization for Community-acquired Pneumonia (Serious Pneumonia)
    • Time Frame: 12 years
    • The number of the first occurences of the hospitalization for community-acquired pneumonia (serious pneumonia)associated with LABA-TIO relative to LABA-ICS in patients with COPD, with one-year follow-up, from the as-treated analysis and from the time-dependent on-treatment analysis based on current exposure is presented. On-treatment exposure was based on analysis of current use during the entire 1-year follow-up, allowing patients to switch treatments.

Participating in This Clinical Trial

Inclusion Criteria

  • New users of long-acting bronchodilators, LABA and tiotropium on the same date or of LABA and ICS, either as a fixed-dose combination or free combination, on the same date between January 2002 and December 2015
  • Diagnosis of COPD and age ≥ 55 years

Exclusion Criteria

  • Less than one year of medical history information prior to the date of combined treatment initiation (cohort entry)
  • Asthma diagnosis

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Boehringer Ingelheim
  • Provider of Information About this Clinical Study
    • Sponsor

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