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

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.

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.

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.

Albuterol/salbutamol will be delivered as a rescue medication via MDI.

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.

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.

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.

Albuterol/salbutamol will be delivered as a rescue medication via MDI.

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.