Randomized, Double-Blind, Chronic Dosing (4 Weeks), Four-Period, Five-Treatment, Incomplete Block, Cross-Over, Multi-Center Study to Assess the Efficacy and Safety of Four Doses of Budesonide Inhalation Aerosol (BD MDI, PT008) Relative to Placebo MDI in Adult Subjects With Mild to Moderate Persistent Asthma

Trial Profile

Randomized, Double-Blind, Chronic Dosing (4 Weeks), Four-Period, Five-Treatment, Incomplete Block, Cross-Over, Multi-Center Study to Assess the Efficacy and Safety of Four Doses of Budesonide Inhalation Aerosol (BD MDI, PT008) Relative to Placebo MDI in Adult Subjects With Mild to Moderate Persistent Asthma

Completed
Phase of Trial: Phase II

Latest Information Update: 08 Jun 2017

At a glance

  • Drugs Budesonide (Primary)
  • Indications Asthma
  • Focus Therapeutic Use
  • Sponsors Pearl Therapeutics
  • Most Recent Events

    • 24 May 2017 Primary endpoint (Change From Baseline in Morning Pre-dose Trough Forced Expiratory Volume in 1 Second (FEV1) at the End of the Treatment Period) has been met, according to the results presented at the 113th International Conference of the American Thoracic Society
    • 24 May 2017 Results presented at the 113th International Conference of the American Thoracic Society
    • 05 May 2017 Status changed from active, no longer recruiting to completed.
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