Comparative Effectiveness of COPD Treatments


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


  • 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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.