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Effectiveness of Triple Therapy in COPD

NCT ID: NCT03724877

Last Updated: 2019-12-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8853 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-10

Study Completion Date

2018-11-12

Brief Summary

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To assess the effectiveness of maintenance treatment of Chronic obstructive pulmonary disease (COPD) with the Long-acting beta2-agonist - long-acting muscarinic antagonists-inhaled corticosteroids (LABA-LAMA-ICS) combination with a LABA-LAMA combination on the risk of COPD exacerbation and the safety on the incidence of community acquired pneumonia.

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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

PROSPECTIVE

Study Groups

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Subjects with Chronic obstructive pulmonary disease (COPD)

Long-acting beta2-agonist-long-acting muscarinic antagonists-inhaled corticosteroids(LABA-LAMA-ICS)

Intervention Type DRUG

(LABA-LAMA-ICS)

Long-acting beta2-agonist-inhaled corticosteroids-long-acting muscarinic antagonists (LABA-LAMA)

Intervention Type DRUG

(LABA-LAMA)

Interventions

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Long-acting beta2-agonist-long-acting muscarinic antagonists-inhaled corticosteroids(LABA-LAMA-ICS)

(LABA-LAMA-ICS)

Intervention Type DRUG

Long-acting beta2-agonist-inhaled corticosteroids-long-acting muscarinic antagonists (LABA-LAMA)

(LABA-LAMA)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* New users of long-acting bronchodilators, Long-acting beta2-agonist (LABA) and long-acting muscarinic antagonists (LAMA) on the same date or of LABA, LAMA and inhaled corticosteroids (ICS), either as a fixed-dose combination (LABA-ICS) or free combination, on the same date between January 2002 and December 2016.
* Diagnosis of Chronic obstructive pulmonary disease (COPD) prior to first maintenance inhaler and age ≥ 55 years at first maintenance inhaler.

Exclusion Criteria

* Less than one year of medical history information prior to the date of combined treatment initiation (study cohort entry)
* Asthma diagnosis prior to study cohort entry
Minimum 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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Clinical Practice Research Datalink

London, , United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1237-0078

Identifier Type: -

Identifier Source: org_study_id

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