At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 46 enrolled
Drug / intervention
AS MDI +1 moredrug
Likely dose
AS MDI 90 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating AS MDI and Proventil for Asthma. Completed, enrolled 46 participants across 5 sites.
Detailed Summary
This is a randomized, cumulative dose, open-label, 2-period crossover, multi-center study to assess the safety, efficacy, PK, and extrapulmonary PD of cumulative doses of AS MDI compared to cumulative doses of Proventil as an active control in subjects with mild to moderate asthma
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedDec 2017
Enrollment StartDec 2017
Primary CompletionMar 2018
TodayJul 2026
First PostedDec 13, 2017
Enrollment StartDec 29, 2017
Primary CompletionMar 26, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 8.6 years ago
Interventions
AS MDIdrug
AS MDI 1+1+2+4+8 inhalations of 90 μg per inhalation
Proventildrug
Proventil 1+1+2+4+8 inhalations of 90 μg per inhalation