Indacaterol as either PulmoSpheres or lactose-blend powder in asthma

• Research type

  Research Study

• Full title

  A multi-centre, randomized, double-blind, double-dummy, multiple-dose, crossover study to evaluate the pharmacodynamics, pharmacokinetics, safety and tolerability of orally inhaled indacaterol administered as either PulmoSpheres or lactose-blend powder via the Concept1 device in adult patients with persistent asthma

• IRAS ID

  85339

• Contact name

  Dave Singh

• Sponsor organisation

  Novartis Pharmaceuticals

• Eudract number

  2011-001825-25

• Research summary

  This study will assess the efficacy, safety, tolerability and pharmacokinetics of two different formulations of indacaterol, both administered via the Concept1 device. The study aims to determine whether the newer formulation has the same clinical benefit as the traditional formulation.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  11/NW/0714

• Date of REC Opinion

  1 Nov 2011

• REC opinion

  Further Information Favourable Opinion