Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD DPI Batefenterol Fluticasone Furoate
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 63
Healthy volunteers: no

Brief summary:
Batefenterol inhalation powder is currently under development as a fixed-dose combination with fluticasone furoate (FF) for the treatment of Chronic Obstructive Pulmonary Disease (COPD).

The present study will administer batefenterol/FF (300/100 micrograms \[mcg\]) for the first time to subjects with COPD, to investigate the safety and tolerability of the combination compared with placebo, and to evaluate the pharmacokinetics and pharmacodynamics profiles of the individual components when administered in combination.

This is a Phase IIa, multicenter, randomized, placebo-controlled, double-blind, parallel group study. Subjects will be randomized (2:1) to one of the following double-blind treatment groups:

Batefenterol/FF 300/100 mcg inhalation powder once daily, or matching placebo inhalation powder once daily.

Subjects will self-administer the study treatments once daily (QD) in the morning for 42 days via a multi-dose dry powder inhaler (DPI) which contains two blister strips. Additionally, an inhaled short acting beta2-receptor agonist, albuterol will be provided from screening to the end of the treatment period for all subjects to use as needed to relieve COPD symptoms. At the end of the treatment period, subjects can resume conventional therapy.

The study will randomize approximately 60 subjects. The total duration of subject participation (from screening to follow-up) will be approximately 8 weeks.

Detailed description:

Arms:
arm 1: Subjects will self-administer batefenterol/fluticasone furoate 300/100 micrograms inhalation powder once daily for 42 days. Albuterol will be provided from screening to Day 42, to use as needed for symptom relief. arm 2: Subjects will self-administer matching placebo inhalation powder once daily for 42 days. Albuterol will be provided from screening to Day 42, to use as needed for symptom relief.

Interventions: intervention 1: Batefenterol + Fluticasone Furoate intervention 2: Placebo intervention 3: Albuterol
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: Albuterol inhalation will be provided as an open-label rescue medication to use as needed, to relieve chronic obstructive pulmonary disease (COPD) symptoms.

Protocol document: