Comparative Effectiveness of COPD Treatments

Boehringer Ingelheim

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

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

Study type: Observational

Funder types: Industry

Identifiers

NCT03376295

0205-0538

Details and patient eligibility

About

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.

Enrollment: 3,954 patients

Sex: All

Ages: Under 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

3,954 participants in 1 patient group

Subjects diagnosed with COPD

Description:

Chronic obstructive pulmonary disease

Treatment:

Drug: LABA and an ICS (LABA-ICS)

Drug: LABA and the LAMA tiotropium (LABA-TIO)