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A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, 12-Week Clinical Study to Assess the Efficacy and Safety of 80 or 160 mcg/Day of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Pediatric Patients 4 Through 11 Years of Age With Persistent Asthma

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Trial Profile

A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, 12-Week Clinical Study to Assess the Efficacy and Safety of 80 or 160 mcg/Day of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Pediatric Patients 4 Through 11 Years of Age With Persistent Asthma

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Nov 2021

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At a glance

  • Drugs Beclometasone (Primary) ; Salbutamol
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Sponsors Teva Branded Pharmaceutical Products R&D

    • Most Recent Events

    • 07 Aug 2017 According to the Teva Pharmaceutical Industries, based on the results of this and other three phase III studies the U.S. Food and Drug Administration (FDA) has approved QVAR RediHaler a breath-actuated inhaler for the maintenance treatment of asthma as a prophylactic therapy in patients 4 years of age and older.
    • 12 Apr 2016 Status changed from active, no longer recruiting to completed.
    • 01 Mar 2016 Planned End Date changed from 1 Feb 2016 to 1 Mar 2016, according to ClinicalTrials.gov record.

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