Effectiveness of Triple Therapy in COPD

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03724877
• Other study ID #: 1237-0078
• Status: Completed
• Start date: November 10, 2018
• Est. completion date: November 12, 2018

Study information

• Verified date: November 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8853
• Est. completion date: November 12, 2018
• Est. primary completion date: November 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Clinical Practice Research Datalink	London

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Hospitalised With Severe Exacerbation	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.	1 year
Primary	Number of Participants Hospitalised With Moderate Exacerbation	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.	1 year
Primary	Number of Participants Hospitalised With Community-acquired Pneumonia (Serious Pneumonia)	The primary outcome event for safety was the occurrence of the first hospitalization for community-acquired pneumonia (serious pneumonia).	1 year
Secondary	The Rate of COPD Exacerbations Over the One-year Follow-up	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.	1 year

External Links

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