A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg OD versus Montelu...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-000548-29

A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg OD versus Montelukast 10mg OD in Adolescent and Adult Subjects with Asthma and Seasonal Allergic Rhinitis Who are Receiving salmeterol/Fluticasone Propionate DISKUS® 100/50mcg BID or Placebo BID

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Extrait

The main objective of this study are to show that fluticasone propionate/salmeterol combination product 100/50mcg (FSC) BID (available as Seretide DISKUS) is superior to montelukast 10mg OD (available as Singulair) as monotherapy for asthma, and that Montelukast administered concurrently with FSC adds no additional benefit to FSC alone in improving asthma control in a population of subjects with allergic asthma.


Critère d'inclusion

  • Persistent asthma and seasonal allergic rhinitis