A pharmacokinetic and pharmacodynamic, randomised, single dose, cross-over, partially blinded study to compare the systemic exposure and the efficacy of a fixed-dose combination of Budesonide-Salmeterol DPI capsule 75-25 μg, Budesonide-Salmeterol DPI capsule 75-12.5 μg, Budesonide-Salmeterol DPI capsule 75-6.25 μg delivered by the Axahaler® versus Serevent® Diskus® 50 μg + Pulmicort® Turbohaler® 100µg co-administration in asthmatic children

Trial Profile

A pharmacokinetic and pharmacodynamic, randomised, single dose, cross-over, partially blinded study to compare the systemic exposure and the efficacy of a fixed-dose combination of Budesonide-Salmeterol DPI capsule 75-25 μg, Budesonide-Salmeterol DPI capsule 75-12.5 μg, Budesonide-Salmeterol DPI capsule 75-6.25 μg delivered by the Axahaler® versus Serevent® Diskus® 50 μg + Pulmicort® Turbohaler® 100µg co-administration in asthmatic children

Recruiting
Phase of Trial: Phase II

Latest Information Update: 18 Dec 2017

At a glance

  • Drugs Budesonide/salmeterol (Primary) ; Budesonide; Salmeterol
  • Indications Asthma
  • Focus Pharmacokinetics
  • Sponsors Laboratoires SMB
  • Most Recent Events

    • 16 Dec 2017 Status changed from planning to recruiting.
    • 06 Dec 2017 New trial record
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