A Dose Ranging Study of Albuterol Sulfate MDI in Co-Suspension Delivery Technology (AS MDI; PT007) in Patients with Asthma

Albuterol–Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma

“…A fixed-dose combination of inhaled albuterol and budesonide, as compared with albuterol alone, as a rescue medication was considered to be most appropriate, because albuterol is the most commonly used rescue medication worldwide, and SABAs are the only class of rescue medication approved by the Food and Drug Administration in the United States. 4,8,23 A new formulation of albuterol and budeso-nide 24,25 in a single pressurized metered-dose inhaler was developed as albuterol-inhaled glucocorticoid rescue therapy for the control of acute asthma symptoms, the treatment and prevention of bronchoconstriction, and the prevention of exacerbations. The primary objective of the MANDALA trial was to evaluate the efficacy and safety of as-needed use of albuterol-budesonide, as compared with as-needed use of albuterol alone, in patients with moderate-to-severe asthma.…”