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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.
ClinicalTrials.gov Identifier: NCT03376295
Recruitment Status : Completed
First Posted : December 18, 2017
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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 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)

Study Design

Study Type : Observational
Actual Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparative Effectiveness of Combination Therapies in COPD
Actual Study Start Date : December 1, 2017
Primary Completion Date : December 31, 2017
Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Number of events hospitalised for severe exacerbation or prescribed with oral coticosteriod, Prednisolone for moderate exacerbation [ Time Frame: 12 years ]

Secondary Outcome Measures :
  1. rate of COPD exacerbations [ Time Frame: 12 years ]

Eligibility Criteria

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.
Criteria

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT03376295


Locations
Canada
Centre for Clinical Epidemiology, McGill University
Montreal, Canada, H3T 1E2
Sponsors and Collaborators
Boehringer Ingelheim
More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03376295     History of Changes
Other Study ID Numbers: 0205-0538
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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