Mobile

A randomized, partially-blinded, single-dose, 4-way crossover study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally inhaled indacaterol maleate administered via the Conce...

Mise à jour : Il y a 5 ans
Référence : EUCTR2009-012600-48

A randomized, partially-blinded, single-dose, 4-way crossover study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally inhaled indacaterol maleate administered via the Concept1 device or as a PulmoSphere® formulation via the Simoon device

Femme et Homme

  • | Pays :
    • -
  • | Organes :
    • -
  • | Spécialités :
    • -

Extrait

To assess the bronchodilator effect of an orally inhaled indacaterol maleate PulmoSphere® formulation in patients with persistent asthma compared with placebo as measured by mean change in FEV1 from baseline to post-dose trough following single dose treatment. Trough is defined as the mean of FEV1 at 23 h 10 min and 23 h 45 min post-dose.

Critère d'inclusion

  • Asthma

Liens