Effectiveness of Triple Therapy in COPD

NCT03724877 | Completed Results

• 1 other identifier: 1237-0078
• Study Type: observational
• Target: 8,853
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

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

  1 year

Study Arms (1)

Subjects with Chronic obstructive pulmonary disease (COPD)

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

Interventions

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

(LABA-LAMA-ICS)

Subjects with Chronic obstructive pulmonary disease (COPD)

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

(LABA-LAMA)

Subjects with Chronic obstructive pulmonary disease (COPD)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Incident new-user cohort design with high-dimensional propensity scores to match the two comparison groups of COPD.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Clinical Practice Research Datalink

London, E14 4PU, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Boehringer Ingelheim, Call Centre
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: October 30, 2018
• Study Start: November 10, 2018
• Primary Completion: November 12, 2018
• Study Completion: November 12, 2018
• Last Updated: December 3, 2019
• Results First Posted: December 3, 2019

Record last verified: 2019-11

Locations

GB (1)