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A 26-Week Open-Label Study to Assess the Long-Term Safety of Fluticasone Propionate Multidose Dry Powder Inhaler and Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler in Patients 12 Years of Age and Older With Persistent Asthma

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Trial Profile

A 26-Week Open-Label Study to Assess the Long-Term Safety of Fluticasone Propionate Multidose Dry Powder Inhaler and Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler in Patients 12 Years of Age and Older With Persistent Asthma

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Nov 2021

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At a glance

  • Drugs Fluticasone propionate (Primary) ; Salmeterol/fluticasone propionate (Primary) ; Salbutamol
  • Indications Asthma
  • Focus Adverse reactions; Registrational
  • Sponsors Teva Branded Pharmaceutical Products R&D

    • Most Recent Events

    • 30 Jan 2017 According to a Teva Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) approved AirDuoTM RespiClick (fluticasone propionate and salmeterol inhalation powder) and ArmonAirTM RespiClick (fluticasone propionate inhalation powder) for adolescent and adult patients with asthma.
    • 07 Nov 2016 According to a Teva Pharmaceuticals media release, data from this trial will be presented at the 2016 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting
    • 28 Jun 2016 According to Teva Pharmaceuticals media release, company announced the U.S. Food and Drug Administration (FDA) has accepted for review the company's new drug applications (NDAs) for two products for adolescent and adult patients with asthma with FDA Regulatory Action expected during the first quarter of 2017.
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