AEROVANT™ (AER 001 Inhalation Powder) in Asthma

• Research type

  Research Study

• Full title

  A Phase IIB Study to Investigate the Treatment-Sparing Effects of AEROVANT™ (AER 001 Inhalation Powder) in Asthma Patients Not Fully Controlled on Current Therapy

• Contact name

  Philip Ind

• Sponsor organisation

  Aerovance Inc.

• Eudract number

  2007-006545-41

• ISRCTN Number

  NA

• Research summary

  This research is funded by Aerovance, Inc. and has been designed to test whether AEROVANT (study drug) is safe and effective in reducing the number of asthma exacerbations (episode of increased asthma symptoms) in asthmatic patients that have initially received inhaled coticosteroids (ICS) and long acting beta-agonists (LABA) and who are not fully controlled on current therapy. Asthma, a chronic disease, brings about airway narrowing, inflammation and mucus secretion. Interleukins, including IL-4 and IL-13 secreted in the airways are believed to be important in mediating the allergic process in asthma. IL-4 also stimulates the production of mucus in the lungs, contributing to airway obstruction. AEROVANT is the dry powder formulation of AER 001, which has been shown to block the actions of IL-4 and IL-13. 500 patients will be enrolled from approximately 86 sites in North America and Europe. The study will be randomised, for every 4 participants enrolled: 3 will receive active study drug twice daily at 1, 3 or 10mg and 1 will receive placebo (inactive drug) twice daily. The study will be blinded so no one will know which treatment patients are receiving until the study is analysed. Patients will make 9 visits to clinic over a period of 17 weeks. Patients will begin the study with a 4-week run-in period during which they will be switched from their current treatment tfluicasone ("a preventer") and salmeterol ("a controller"). Patients will then enter a 4-week stabilisation period (where they will add-on the study drug to their currenfluicasone and salmeterol treatment) followed by an 8-week treatment withdrawal period (patients will continue to receive study drug but salmeterol will be stopped anfluicasone treatment gradually reduced and stopped). Patients will be enrolled in this study until they experience an exacerbation or their 9 visits are complete.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  08/H0706/78

• Date of REC Opinion

  8 Oct 2008

• REC opinion

  Further Information Favourable Opinion