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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)

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Trial Profile

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)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 10 Jun 2021

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At a glance

  • Drugs Salbutamol (Primary)
  • Indications Asthma
  • Focus Therapeutic Use
  • Acronyms ASPEN
  • Sponsors AstraZeneca

    • Most Recent Events

    • 04 Jun 2021 Results (n=132) assessed the efficacy and safety of albuterol sulfate pressurised inhalation suspension via metered-dose inhaler (AS MDI) versus Proventil in order to determine the optimal dose of AS MDI to take to Phase III clinical trials, published in the Clinical Drug Investigation.
    • 09 Apr 2018 Status changed from recruiting to completed.
    • 16 Mar 2018 Planned End Date changed from 15 Apr 2018 to 16 Apr 2018.
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