Study to Compare PT007 to Placebo MDI and Open-Label Proventil® HFA in Adult and Adolescent Subjects With Asthma
Study identifier:D6930C00001
ClinicalTrials.gov identifier:NCT03364608
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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)
Medical condition
asthma
Phase
Phase 2
Healthy volunteers
No
Study drug
AS MDI 90 μg, AS MDI 180 µg, Proventil 90 μg, Proventil 180 μg
Sex
All
Actual Enrollment
86
Study type
Interventional
Age
12 Years - 65 Years
Date
Study Start Date: 15 Dec 2017
Primary Completion Date: 30 Mar 2018
Study Completion Date: 30 Mar 2018
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2019 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| 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 |
