Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: efficacy dry powder inhaler vilanterol batefenterol
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 325
Healthy volunteers: no

Brief summary:
Batefenterol is a novel bifunctional molecule that combines muscarinic antagonism and beta2-agonism in a single molecule. This is a multicenter, randomized, placebo-controlled, double-blind, parallel group study primarily designed to assess the dose response, efficacy and safety of five dose regimens of batefenterol administered via the dry powder inhaler (DPI) once-daily in the morning for 42 days in subjects with COPD. The information obtained from this study will be used to select the minimal, optimally effective and safe dose of batefenterol and also to evaluate the pharmacokinetic profile and established pharmacodynamic (PD) responses of batefenterol. These data will support for future studies with batefenterol in COPD subjects.

The study will consist of a pre-screening visit, screening visit; a run-in period (2 weeks), treatment period of 42 days and a follow-up visit 7 days post-treatment. The total duration of the study for each subject will be approximately 9 weeks. Approximately 460 subjects will be screened in order to randomize approximately 320 subjects, assuming that 280 subjects will complete the study. During treatment period, subjects will be randomized to one of the following treatments delivered via DPI once daily in the morning: Batefenterol 37.5 mcg, 75 mcg, 150 mcg, 300 mcg and 600 mcg, umeclidinium/vilanterol (UMEC/VI) 62.5/25 mcg and placebo. All subjects will receive supplemental albuterol/salbutamol to be used on an as-needed basis (rescue medication) throughout the study.

Detailed description:

Arms:
arm 1: Each subject will receive batefenterol 37.5 mcg (1 actuation) once daily via DPI in the morning for 42 days of treatment period. arm 2: Each subject will receive batefenterol 75 mcg (1 actuation) once daily via DPI in the morning for 42 days of treatment period. arm 3: Each subject will receive batefenterol 150 mcg (1 actuation) once daily via DPI in the morning for 42 days of treatment period. arm 4: Each subject will receive batefenterol 300 mcg (1 actuation) once daily via DPI in the morning for 42 days of treatment period. arm 5: Each subject will receive batefenterol 600 mcg (1 actuation) once daily via DPI in the morning for 42 days of treatment period. arm 6: Each subject will receive UMEC/VI 62.5/25 mcg (1 actuation) once daily via DPI in the morning for 42 days of treatment period. arm 7: Each subject will receive placebo (1 actuation) once daily via DPI in the morning for 42 days of treatment period.

Interventions: intervention 1: Batefenterol intervention 2: Umeclidinium/ Vilanterol intervention 3: Placebo
Intervention descriptions: intervention 1: Batefenterol will be provided as dry white powder for inhalation via a DPI with 30 doses (2 strips with 30 blisters per strip). First strip will contain lactose and the second strip will contain batefenterol blended with lactose with a unit dose strength of 37.5 mcg, 75 mcg, 150 mcg, 300 mcg, or 600 mcg per blister intervention 2: Umeclidinium/Vilanterol will be provided as dry white powder for inhalation via a DPI with 30 doses (2 strips with 30 blisters per strip). First strip will contain umeclidinium blended with lactose and magnesium stearate with a unit dose strength of 62.5 mcg per blister and the second strip will contain vilanterol blended with lactose and magnesium stearate with a unit dose strength of 25 mcg per blister intervention 3: Placebo will be provided as dry white powder for inhalation via a DPI with 30 doses (2 strips with 30 blisters per strip) containing lactose

Protocol document: