Comparative Effectiveness of COPD Treatments

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Comparative Effectiveness of Combination Therapies in COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03376295
• Other study ID #: 0205-0538
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: July 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3954
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• LABA and the LAMA tiotropium (LABA-TIO)
combinational drug
• LABA and an ICS (LABA-ICS)
combinational drug

Locations

Country	Name	City	State
Canada	Centre for Clinical Epidemiology, McGill University	Montreal

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Observed Patients With First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation to Occur After Cohort Entry	The number of observed patients with first COPD exacerbation after cohort entry was reported. The event of time to first COPD exacerbation to occur after cohort entry was defined as a hospitalization for COPD (severe exacerbation) or the prescription of an oral corticosteroid, namely prednisolone (moderate exacerbation) to occur after cohort entry with one-year follow-up, from the as-treated analysis.	12 Years
Secondary	The Rate of COPD Exacerbations	Incidence rates and rate ratios of the moderate or severe exacerbation associated with LABA-TIO relative to LABA-ICS in patients with COPD, with one-year follow-up, from the as-treated analysis, estimated.	12 years
Secondary	The Occurrence of the First Hospitalization for Community-acquired Pneumonia (Serious Pneumonia)	The number of the first occurences of the hospitalization for community-acquired pneumonia (serious pneumonia)associated with LABA-TIO relative to LABA-ICS in patients with COPD, with one-year follow-up, from the as-treated analysis and from the time-dependent on-treatment analysis based on current exposure is presented. On-treatment exposure was based on analysis of current use during the entire 1-year follow-up, allowing patients to switch treatments.	12 years

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