- Reversibility of Disease: Demonstrated historical reversibility of >=12% and >=200 milliliter (mL) reversibility of forced expiratory volume in one second (FEV1) within 10-40 minutes following 2-4 inhalations of albuterol/salbutamol inhalation aerosol (or equivalent nebulized treatment with albuterol/salbutamol solution) within 24 months of Visit 1.