Phase 1 PK Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients

AERO-007 is a propriety inhalation solution formulation of fixed-dose combination of LABA+LAMA (indacaterol and glycopyrrolate) for delivery using a general-purpose nebulizer device. Combination of a long-acting beta-agonist (LABA) bronchodilator and a long-acting muscarinic antagonist (LAMA) bronchodilator is the preferred choice for initial pharmacotherapy for COPD patients with high symptom severity, frequently experiencing breathlessness, and patients with high exacerbation risk. Although there are currently multiple LABA+LAMA combination bronchodilators available in handheld inhalers, a significant number 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. In this phase 1 study, 24 healthy volunteers will be randomized to receive single doses of two study treatments (AERO-002 and active comparator) in a crossover design administered by random sequence. Study assessments will be performed pre- and post-dose for 24 hours. Treatment visits will be separated by a washout period of 7 days.