NCT03376932

Effectiveness of Fluticasone Furoate/ Umeclidinium/ Vilanterol (FF/UMEC/VI) Using the Connected Inhaler System (CIS) as Compared With Fluticasone Proprionate/ Salmeterol (FP/SAL) Plus Tiotropium (TIO) in Inadequately Controlled Asthma

A Randomised Open-label Study to Compare the Effectiveness of the Fixed Dose Combination of FF/UMEC/VI (Using the Connected Inhaler System) With the Combination of FP/SAL Plus Tiotropium (Without the Connected Inhaler System) in Participants With Inadequately Controlled Asthma

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Asthma is a common, chronic respiratory disease affecting 1-18 percent of the population. It is accepted that much of the uncontrolled asthma is due to poor adherence and asthma outcomes in such cases may improve simply by increasing adherence to available treatments. GlaxoSmithKline (GSK) has developed a sensor, which clips on to the ELLIPTA® dry powder inhaler (DPI). This will inform subjects if/when they have taken their medication that is in the ELLIPTA inhaler, as well as other information, including: asthma management strategies, tracking of symptoms, asthma triggers, medication reminders and daily asthma forecasts. The sensors, application (app), and provider portal that provide data are subsequently described as the CIS. The combination of once-daily FF/UMEC/VI with the CIS will improve the disease management and adherence. Thus, this study is designed to study the effectiveness and adherence of single inhaler triple therapy (SITT) of FF/UMEC/VI with the CIS as compared to multiple inhaler triple therapy (MITT) of the combination of FP/SAL plus TIO without CIS in subjects with inadequately controlled asthma. The study randomization will be stratified by pre-study inhaled corticosteroids (ICS) dosage strength (mid- or high-dose). Subjects will be randomized in a 1:1 ratio to receive either FF/UMEC/VI delivered via the ELLIPTA DPI with the CIS or FP/SAL delivered via the DISKUS® DPI (with sensor only) plus TIO delivered via the RESPIMAT inhaler (without sensor). The maximum study duration will be approximately 29 weeks, which comprised of prescreen/ screening/ randomization period of up to 4 weeks, 24-week treatment period and a 1-week follow-up period. Approximately 1006 subjects will be randomized in the study. ELLIPTA and DISKUS are registered trademarks of GlaxoSmithKline (GSK) group of companies.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	FF/UMEC/VI	FF/UMEC/VI will be given as dry white powder delivered via the ELLIPTA DPI once daily in the morning or evening. The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 100 mcg or 200 mcg in each blister and the second strip contains UMEC 62.5 mcg and VI 25 mcg in each blister.
DRUG	FP/SAL	FP/SAL will be given as dry white powder delivered via the DISKUS DPI twice daily in the morning or evening. The DISKUS DPI holds a single blister strip with 60 blisters, which contains FP 250 mcg or 500 mcg and SAL 50 mcg per blister.
DRUG	Tiotropium	TIO will be given as clear, colorless, inhalation solution delivered via RESPIMAT inhaler once daily in the morning or evening. The RESPIMAT inhaler will contain 60 puffs with 2.5 mcg TIO per puff.
DRUG	Albuterol/salbutamol	Albuterol/salbutamol will be delivered as a rescue medication via MDI.
DEVICE	ELLIPTA DPI	The ELLIPTA device will be used to administer FF/UMEC/VI once daily. The ELLIPTA DPI is a molded plastic two-sided inhaler that can hold two individual blister strips, which contain powder formulation for oral inhalation.
DEVICE	DISKUS DPI	The DISKUS device will be used to administer FP/SAL twice daily. The DISKUS DPI is a plastic inhalation delivery system containing a single-foil blister strip of a powder formulation of FP/SAL for oral inhalation.
DEVICE	RESPIMAT inhaler	The RESPIMAT inhaler will be used to administer TIO once daily. The RESPIMAT inhaler has a solution filled into a polyethylene/polypropylene cartridge with a polypropylene cap with integrated silicone sealing ring. The cartridge is enclosed within an aluminum cylinder.
DEVICE	Metered Dose Inhaler	Albuterol/salbutamol will be delivered as a rescue medication via MDI.
DEVICE	Connected Inhaler System	The CIS will consist of a sensor, which clips on to the ELLIPTA DPI. This will inform subject's if/when they have taken their medication that is in the ELLIPTA inhaler. The sensor will measure when the ELLIPTA inhaler mouth piece cover is fully opened and closed and this data can be fed back, via the app on a mobile device to the subject. The sensors, app, and provider portal that provide data are subsequently described as the CIS.

Timeline

• Start date: 2019-01-18
• Primary completion: 2021-02-03
• Completion: 2021-02-03
• First posted: 2017-12-19
• Last updated: 2019-03-25

Regulatory

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