Comparative Effectiveness of COPD Treatments

Comparative Effectiveness of Combination Therapies in COPD

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: LABA and the LAMA tiotropium (LABA-TIO); Drug: LABA and an ICS (LABA-ICS)

• Study Type: Observational
• Enrollment (Actual): 3954

Contacts and Locations

Study Locations

• Canada
  • Montreal, Canada, H3T 1E2
    • Centre for Clinical Epidemiology, McGill University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 55 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The base cohort will consist of all patients with a diagnosis of COPD from 1 January 1995 until 31 December 2015 who subsequently received at least one prescription for a long-acting bronchodilator, either LABA or tiotropium, or for an inhaled corticosteroid, alone or in combination, from 1 January 2002 until 31 December 2015.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects diagnosed with COPD; Chronic obstructive pulmonary disease	Drug: LABA and the LAMA tiotropium (LABA-TIO); combinational drug; Other Names: FORVENT, SPIRIVA, SRIVASSO; Drug: LABA and an ICS (LABA-ICS); combinational drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Observed Patients With First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation to Occur After Cohort Entry	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.	12 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Rate of COPD Exacerbations	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.	12 years
The Occurrence of the First Hospitalization for Community-acquired Pneumonia (Serious Pneumonia)	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.	12 years

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide
• Other Study ID Numbers: 0205-0538

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No