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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)

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)

Completed
Phase of Trial: Phase II

Latest Information Update: 11 Jun 2018

At a glance

  • Drugs Salbutamol (Primary)
  • Indications Asthma
  • Focus Therapeutic Use
  • Sponsors AstraZeneca
  • Most Recent Events

    • 09 Apr 2018 Status changed from recruiting to completed.
    • 16 Mar 2018 Planned End Date changed from 15 Apr 2018 to 16 Apr 2018.
    • 16 Mar 2018 Planned primary completion date changed from 15 Apr 2018 to 16 Apr 2018.
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