Comparative Effectiveness of COPD Treatments

NCT03376295 | Completed Results FDA Drug

• 1 other identifier: 0205-0538
• Study Type: observational
• Target: 3,954
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The Rate of COPD Exacerbations

  12 years

• The Occurrence of the First Hospitalization for Community-acquired Pneumonia (Serious Pneumonia)

  12 years

Study Arms (1)

Subjects diagnosed with COPD

Chronic obstructive pulmonary disease

Drug: LABA and the LAMA tiotropium (LABA-TIO); Drug: LABA and an ICS (LABA-ICS)

Interventions

LABA and the LAMA tiotropium (LABA-TIO) DRUG

combinational drug

Also known as: FORVENT, SPIRIVA, SRIVASSO

Subjects diagnosed with COPD

LABA and an ICS (LABA-ICS) DRUG

combinational drug

Subjects diagnosed with COPD

Eligibility Criteria

• Age: Up to 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The base cohort will consist of all patients with a diagnosis of COPD from 1 January 1995 until 31 December 2015 who subsequently received at least one prescription for a long-acting bronchodilator, either LABA or tiotropium, or for an inhaled corticosteroid, alone or in combination, from 1 January 2002 until 31 December 2015.

You may qualify if:

• 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

You may not qualify if:

• Less than one year of medical history information prior to the date of combined treatment initiation (cohort entry)
• Asthma diagnosis

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Centre for Clinical Epidemiology, McGill University

Montreal, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Limitations and Caveats

The continuous combination treatment duration was short because patients either discontinued one of the components or added another agent.

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: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 18, 2017
• Study Start: December 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: July 24, 2019
• Results First Posted: July 8, 2019

Record last verified: 2019-07

Locations

CA (1)