Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients

Combination of a long-acting beta-agonist (LABA) bronchodilator and a long-acting muscarinic antagonist (LAMA) bronchodilator is the preferred choice for initial therapy for patients with chronic obstructive pulmonary disease (COPD). Although there are currently multiple LABA+LAMA combination bronchodilators available in metered dose inhalers (MDIs), dry powder inhalers (DPI), and soft mist inhalers (SMI), a significant percentage of COPD patients, generally high risk and older patients, do not receive optimal benefit from inhalers. Nebulized delivery provides an effective alternative where disease management is sub optimal. To date there are no approved LABA+LAMA combinations available by nebulization. AERO-007 is a propriety inhalation solution formulation of fixed-dose combination of LABA+LAMA (indacaterol, AERO-001 and glycopyrrolate, AERO-002) for delivery in a general purpose nebulizer device. A phase 2a, single-dose, dose-ranging study of AERO-007 has been completed in participants with COPD at two dose levels (100/50 µg and 200/100 µg). AERO-007 at both low and high doses was well tolerated with robust, clinically meaningful and statistically significant bronchodilation with rapid onset of action that was sustained for 24 hours. The objective of this phase 2b study is to determine the optimal doses of the monotherapy components of AERO-007 and to assess the safety, PK and bronchodilation profile of AERO-007 following 14 days of dosing in participants with COPD.