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A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler in Patients Aged 4 Through 11 Years With Persistent Asthma

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Trial Profile

A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler in Patients Aged 4 Through 11 Years 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)
  • Indications Asthma
  • Focus Therapeutic Use
  • Sponsors Teva Branded Pharmaceutical Products R&D

    • Most Recent Events

    • 18 Mar 2020 Primary endpoint (For FS MDPI versus Fp MDPI: the change from baseline in 1-hour postdose percent predicted morning FEV1 at week 12) has not been met as per results published in the ClinicalTrials.gov Trial Registry
    • 18 Mar 2020 Primary endpoint (For Fp MDPI versus placebo: the change from baseline in weekly average of the percent predicted trough morning forced expiratory volume in 1 second (FEV1) at week 12) has been met as per results published in the ClinicalTrials.gov Trial Registry
    • 18 Mar 2020 Results published in the ClinicalTrials.gov Trial Registry

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