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