Batefenterol/Fluticasone Furoate in Treatment of Chronic Obstructive Pulmonary Disease

Batefenterol and Fluticasone Furoate (FF) will be provided as a fixed-dose combination in a dry powder inhaler (DPI), for oral inhalation once every morning, for 42 days. The DPI will consist of 2 strips of 30 blisters each, containing 300 microgram (mcg) batefenterol per blister in one strip and 100 mcg FF per blister in another strip. Both drugs will be available in a micronized form, blended with lactose monohydrate.

Placebo will be provided in a DPI, for oral inhalation once every morning, for 42 days. The DPI will consist of 2 matching strips of 30 blisters each, with each blister containing lactose monohydrate and no active pharmaceutical ingredient.

Albuterol inhalation will be provided as an open-label rescue medication to use as needed, to relieve chronic obstructive pulmonary disease (COPD) symptoms.