Study to Compare PT007 to Placebo MDI and Open-Label Proventil® HFA in Adult and Adolescent Subjects With Asthma

Summary

This is a randomized, double-blind, single-dose, placebo-controlled, 5-period, 5-treatment, crossover, multi-center study to assess the bronchodilatory effect and safety of 2 dose levels of Albuterol Sulfate Pressurized Inhalation Suspension (hereafter referred to as AS MDI), 90 μg and 180 μg, compared with placebo for AS MDI (hereafter referred to as Placebo MDI) and open-label Proventil® hydrofluoroalkane (HFA; hereafter referred to as Proventil) 90 μg and 180 μg in adult and adolescent subjects with mild to moderate asthma. This study design utilizes 10 treatment sequences.

Timeline

Start

2017-12-15

Primary completion

2018-03-30

Completion

2018-03-30

Outcome

Met primary endpoint

paper In ANTORA, 90 μg and 180 μg doses of AS MDI and Proventil were significantly superior to placebo MDI (p < 0.0001), PMID 34089147 ↗

paper AS MDI was non-inferior to Proventil at both doses, based on a margin of 100 mL. PMID 34089147 ↗

Publications

• Cappelletti C, Maes A, Rossman K, Gillen M, LaForce C, Kerwin EM, Reisner C. Dose-Ranging and Cumulative Dose Studies of Albuterol Sulfate MDI in Co-Suspension Delivery Technology (AS MDI; PT007) in Patients with Asthma: the ASPEN and ANTORA Trials. Clin Drug Investig. 2021 Jun;41(6):579-590. doi: 10.1007/s40261-021-01040-7. Epub 2021 Jun 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Salbutamol	Unknown	90 ug	Inhaled
Subject	Salbutamol	Unknown	180 ug	Inhaled

Indications