Study identifier:D6930C00001
ClinicalTrials.gov identifier:NCT03364608
EudraCT identifier:N/A
CTIS identifier:N/A
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)
asthma
Phase 2
No
AS MDI 90 μg, AS MDI 180 µg, Proventil 90 μg, Proventil 180 μg
All
86
Interventional
12 Years - 65 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jul 2019 by AstraZeneca
AstraZeneca
-
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.
This is a 5-period crossover study. Each Treatment Period is 1 day. Subjects will receive a single dose of randomized study drug at each of the 5 Treatment Visits (Visits 2, 3, 4, 5, and 6), with a 3- to 7-day Washout Period between Treatment Visits.
Location
Location
Winter Park, FL, United States, 32789
Location
Medford, OR, United States, 97504
Location
St. Louis, MO, United States, 63141
Location
Raleigh, NC, United States, 27607
Location
North Dartmouth, MA, United States, 02747
Location
Rolling Hills Estate, CA, United States, 90274
Location
Stockton, CA, United States, 95207
Location
Spartanburg, SC, United States, 29303
Arms | Assigned Interventions |
---|---|
Experimental: • AS MDI 90 µg (2 actuations of 45 µg/actuation) | Drug: AS MDI 90 μg AS MDI 90 μg (2 actuations of 45 μg/actuation) Other Name: AS MDI |
Experimental: • AS MDI 180 µg (2 actuations of 90 µg/actuation) | Drug: AS MDI 180 µg AS MDI 180 μg (2 actuations of 90 μg/actuation) Other Name: AS MDI |
Placebo Comparator: • Placebo MDI (2 actuations) | Other: Placebo MDI Placebo MDI (2 actuations) Other Name: Placebo MDI |
Active Comparator: • Proventil 90 µg (1 actuation of 90 µg/actuation) | Drug: Proventil 90 μg Proventil 90 μg (1 actuation of 90 μg/actuation) Other Name: Proventil |
Active Comparator: • Proventil 180 µg (2 actuations of 90 µg/actuation) | Drug: Proventil 180 μg Proventil 180 μg (2 actuations of 90 μg/actuation) Other Name: Proventil |
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