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
Phase of Trial: Phase II
Latest Information Update: 27 Dec 2018
At a glance
- Drugs Budesonide/salmeterol (Primary) ; Budesonide; Salmeterol
- Indications Asthma
- Focus Pharmacokinetics
- Sponsors Laboratoires SMB
- 21 Dec 2018 Status changed from recruiting to completed.
- 16 Dec 2017 Status changed from planning to recruiting.
- 06 Dec 2017 New trial record