Comparative Effectiveness of COPD Treatments

NCT ID: NCT03376295

Last Updated: 2019-07-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3954 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-01

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Subjects diagnosed with COPD

Chronic obstructive pulmonary disease

LABA and the LAMA tiotropium (LABA-TIO)

Intervention Type DRUG

combinational drug

LABA and an ICS (LABA-ICS)

Intervention Type DRUG

combinational drug

Interventions

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LABA and the LAMA tiotropium (LABA-TIO)

combinational drug

Intervention Type DRUG

LABA and an ICS (LABA-ICS)

combinational drug

Intervention Type DRUG

Other Intervention Names

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FORVENT, SPIRIVA, SRIVASSO

Eligibility Criteria

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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
Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre for Clinical Epidemiology, McGill University

Montreal, , Canada

Site Status

Countries

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Canada

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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0205-0538

Identifier Type: -

Identifier Source: org_study_id

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