Assessment of the safety, efficacy, PK, and extrapulmonary pharmacodynamics (PD) of Albuterol Sulfate Pressurized Inhalation Suspension (hereafter referred to as AS MDI) compared to Proventil as an active control in subjects with asthma
Study identifier:D6930C00002
ClinicalTrials.gov identifier:NCT03371459
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A randomized, cumulative dose, open-label, 2-period crossover, multi-center study to assess the safety, efficacy, PK, and extrapulmonary pharmacodynamics (PD) of cumulative doses of Albuterol Sulfate Pressurized Inhalation Suspension (hereafter referred to as AS MDI) compared to cumulative doses of Proventil® hydrofluoroalkane (HFA; hereafter referred to as Proventil) as an active control in subjects with mild to moderate asthma (ASPEN)
Medical condition
asthma
Phase
Phase 2
Healthy volunteers
No
Study drug
AS MDI, Proventil
Sex
All
Actual Enrollment
46
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 29 Dec 2017
Primary Completion Date: 26 Mar 2018
Study Completion Date: 26 Mar 2018
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Jun 2019 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: AS MDI AS MDI 1+1+2+4+8 inhalations of 90 μg per inhalation | Drug: AS MDI AS MDI 1+1+2+4+8 inhalations of 90 μg per inhalation Other Name: AS MDI |
| Active Comparator: Proventil Proventil 1+1+2+4+8 inhalations of 90 μg per inhalation | Drug: Proventil Proventil 1+1+2+4+8 inhalations of 90 μg per inhalation Other Name: Proventil |
