NCT02799784

An Efficacy Study of Umeclidinium/Vilanterol With Tiotropium/Olodaterol in COPD Patients

A Randomized, Open-Label, 8-Week Cross-Over Study to Compare Umeclidinium/Vilanterol With Tiotropium/Olodaterol Once-Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 236 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the effect of umeclidinium/vilanterol (UMEC/VI) versus tiotropium/olodaterol (TIO/OLO) in subjects with moderated COPD. This is a multicentre, randomized, open label, 2 period crossover complete block design study. Eligible subjects, who complete a 2-week run-in period, will be randomized to receive a sequence consisting of UMEC/VI inhalation powder (62.5/25 microgram \[mcg\] once-daily \[QD\]) administered as 1 inhalation via the ELLIPTA® Inhaler and TIO/OLO 5/5 mcg inhalation spray administered as 2 inhalations via the RESPIMAT® inhaler, for 8 weeks each. This will be followed by a 3-week washout period and one-week follow-up period. The total duration of subject participation in the study will be approximately 22 weeks. ELLIPTA is a registered trademark of the GlaxoSmithKline group of companies. RESPIMAT is a registered trademark of Boehringer Ingelheim.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DRUG	UMEC/VI	ELLIPTA dry powder inhaler (DPI) will contain a total of 30 doses. Each DPI will be comprised of two double-foil, laminate blister strips. Each blister of one strip will consist of 62.5 mcg of UMEC blended with lactose and magnesium stearate while each blister of other strip will consist of 25 mcg of VI blended with lactose and magnesium stearate. Each actuation of the DPI will deliver the contents of one blister from each strip simultaneously
DRUG	TIO/OLO	TIO/OLO inhalation spray will be supplied as an inhalation spray delivered using a RESPIMAT inhaler. Each actuation from the RESPIMAT inhaler delivers 3.124 mcg tiotropium bromide monohydrate (equivalent to 2.5 mcg tiotropium) and 2.736 mcg olodaterol hydrochloride (equivalent to 2.5 mcg olodaterol)
DRUG	Albuterol/salbutamol	Albuterol/salbutamol will be supplied as an inhalation spray via metered dose inhaler and will be issued for reversibility testing at Visit 1. Albuterol/salbutamol will be permitted throughout the study for use as-needed

Timeline

• Start date: 2016-07-14
• Primary completion: 2017-04-27
• Completion: 2017-04-27
• First posted: 2016-06-15
• Last updated: 2018-07-02
• Results posted: 2018-07-02

Locations

35 sites across 4 countries: United States, Germany, Spain, United Kingdom

Regulatory

• FDA-regulated drug study