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Comparative Effectiveness of COPD Treatments

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03376295
Recruitment Status : Completed
First Posted : December 18, 2017
Results First Posted : July 8, 2019
Last Update Posted : July 24, 2019
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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.

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Drug: LABA and the LAMA tiotropium (LABA-TIO) Drug: LABA and an ICS (LABA-ICS)

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Study Type : Observational
Actual Enrollment : 3954 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparative Effectiveness of Combination Therapies in COPD
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort Intervention/treatment
Subjects diagnosed with COPD
Chronic obstructive pulmonary disease
Drug: LABA and the LAMA tiotropium (LABA-TIO)
combinational drug

Drug: LABA and an ICS (LABA-ICS)
combinational drug

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03376295

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Centre for Clinical Epidemiology, McGill University
Montreal, Canada, H3T 1E2
Sponsors and Collaborators
Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT03376295    
Other Study ID Numbers: 0205-0538
First Posted: December 18, 2017    Key Record Dates
Results First Posted: July 8, 2019
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action