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OpenTrials
Completed

NCT Number: NCT03724877

Effectiveness of Triple Therapy in COPD

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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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Practice Research Datalink

London, E14 4PU, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

(LABA-LAMA-ICS)

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

Drug

(LABA-LAMA)

Primary outcomes

  1. Number of Participants Hospitalised With Severe Exacerbation

    Time frame: 1 year

    The primary outcome event for effectiveness was the first COPD exacerbation to occur after cohort entry. The event was defined as a hospitalization with a primary diagnosis of COPD (severe exacerbation) is presented.

  2. Number of Participants Hospitalised With Moderate Exacerbation

    Time frame: 1 year

    The primary outcome event for effectiveness was the first COPD exacerbation to occur after cohort entry. The event was defined as a hospitalization with the prescription of an oral corticosteroid, namely prednisolone (moderate exacerbation) is presented.

  3. Number of Participants Hospitalised With Community-acquired Pneumonia (Serious Pneumonia)

    Time frame: 1 year

    The primary outcome event for safety was the occurrence of the first hospitalization for community-acquired pneumonia (serious pneumonia).

Secondary outcomes

  1. The Rate of COPD Exacerbations Over the One-year Follow-up

    Time frame: 1 year

    This outcome was based on the number of hospitalizations and on the number of courses of treatment with an oral corticosteroid. A gap of at least 30 days between treatment courses was required to consider the exacerbations as separate events.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Comparative Effectiveness of Triple Therapy in COPD: A New-user Cohort Study

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 30, 2018
Registry last updated
Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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