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Chronic-Dose Safety and Efficacy Study of a Bronchodilator Inhaler in Pediatric Asthmatics

Trial Profile

Chronic-Dose Safety and Efficacy Study of a Bronchodilator Inhaler in Pediatric Asthmatics

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Apr 2020

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At a glance

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

    • 29 Apr 2016 The US FDA has approved ProAir RespiClick (albuterol sulfate) Inhalation Powder for the treatment or prevention of bronchospasm in children 4 to 11 years of age with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.
    • 30 Oct 2014 According to Teva Pharmaceutical Industries pipeline, company plans to submit an NDA to the FDA in 2015, based on the results of this study.
    • 16 Aug 2012 Actual end date (1 Jul 2008) added as reported by ClinicalTrials.gov.
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