NCT05169424

A Study in the US Based on Pharmacy and Medical Claims That Compares How Well Stiolto® and Trelegy® Work in People With Chronic Obstructive Pulmonary Disease (COPD)

Comparison of Exacerbation Risk and Health Outcomes in Maintenance Treatment naïve Chronic Obstructive Pulmonary Disease (COPD) Patients Using Stiolto Versus Trelegy, a Real-World Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 9,117 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This study looks at data from people with chronic obstructive pulmonary disease (COPD). Some used Stiolto Respimat and the others Trelegy Ellipta as their first treatment for COPD. The purpose of this study is to find out how well the treatments worked. Researchers compare the time to first COPD flare-up (exacerbation) between the 2 treatments. The study analyses anonymous data from pharmacy claims collected over 3.5 years.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DEVICE	Trelegy Ellipta	Trelegy Ellipta
DEVICE	Stiolto Respimat	Stiolto Respimat
DRUG	Tiotropium + Olodaterol (5/5 mcg)	Tiotropium + Olodaterol (5/5 mcg)
DRUG	Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg)	Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg)

Timeline

• Start date: 2021-12-17
• Primary completion: 2021-12-27
• Completion: 2021-12-27
• First posted: 2021-12-27
• Last updated: 2023-10-19
• Results posted: 2023-10-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study