At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Single Dose, Placebo-controlled, 5-Period, 5-Treatment, Crossover, Multi-center, Dose-ranging Study to Compare PT007 to Placebo MDI and Open-Label Proventil® HFA in Adult and Adolescent Subjects With Mild to Moderate Asthma (ANTORA)
In Brief
A Phase 2 clinical trial evaluating AS MDI 90 μg, AS MDI 180 µg, and 3 other interventions for Asthma. Completed, enrolled 86 participants across 10 sites.
Detailed 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.
Study Details
Timeline
Interventions
AS MDI 90 μg (2 actuations of 45 μg/actuation)
AS MDI 180 μg (2 actuations of 90 μg/actuation)
Placebo MDI (2 actuations)
Proventil 90 μg (1 actuation of 90 μg/actuation)
Proventil 180 μg (2 actuations of 90 μg/actuation)