NCT05127304

A Study Using US Medical and Pharmacy Claim Records to Compare the Resource Use, Cost, and Outcomes of People With COPD Who Take Either Tiotropium + Olodaterol or Fluticasone + Umeclidinium + Vilanterol

Health Care Resource Utilization, Cost and Other Outcomes of Patients Diagnosed With COPD Initiating Tiotropium Bromide/Olodaterol Versus Fluticasone Furoate/Umeclidinium/Vilanterol

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 11,316 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to estimate disease-related and all-cause burden and clinical outcomes of interest following initiation of chronic obstructive lung disease (COPD) maintenance therapy with Tiotropium Bromide/Olodaterol (TIO/OLO) or Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI).

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DEVICE	Trelegy Ellipta	Trelegy Ellipta with Furoate/Umeclidinium/Vilanterol
DEVICE	Stiolto Respimat	Stiolto Respimat with Tiotropium Bromide/Olodaterol
DRUG	Furoate/Umeclidinium/Vilanterol	Furoate/Umeclidinium/Vilanterol
DRUG	Tiotropium Bromide/Olodaterol	Tiotropium Bromide/Olodaterol

Timeline

• Start date: 2021-02-26
• Primary completion: 2022-02-03
• Completion: 2022-02-03
• First posted: 2021-11-19
• Last updated: 2023-11-13
• Results posted: 2023-11-13

Locations

1 site across 1 country: United States

Regulatory

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