A dose-ranging study using QAW039 in patients with allergic asthma

• Research type

  Research Study

• Full title

  A randomized, placebo-controlled, dose-ranging, multi-centre trial of QAW039 (1-450 mg p.o.), to investigate the effect on FEV1 and ACQ in patients with moderate-to-severe, persistent, allergic asthma, inadequately controlled with ICS therapy.

• IRAS ID

  81741

• Contact name

  Amr Radwan

• Sponsor organisation

  Novartis Pharmaceuticals UK Ltd

• Eudract number

  2011-001062-18

• Research summary

  This is a Phase IIb study designed to find the dose of QAW039 with the best risk/benefit ratio for patients with persistent, moderate to severe allergic asthma that does not respond to inhaled corticosteriod therapy (budesonide). The data generated will be used to select the optimum dosing regimen for subsequent Phase III studies. It is a placebo-controlled, dose-ranging study using QAW039 in male and female patients aged between 18 and 65 years who fit the inclusion and exclusion criteria. It is hoped that globally 950 patients will be randomised. 9 of these will be at 3 UK centres. QAW039 and matching placebo will be supplied in 4 different strengths which will be taken once or twice daily by the patients depending on which treatment arm they are allocated to. Patients will maintain a dose of budesonide 200 micrograms for the duration of the study. There will be a total of 15 treatment arms in the study and treatment will be allocated at random using an interactive computerised system which leaves the patient, study personnel and Sponsor blinded to the treatment. The study has a run-in period of up to 35 days and comprises of 10 visits over 16 weeks. Patients will undergo a variety of investigations, including an assessment of their lung function, heart tracing and blood sampling. They will also fill in diaries and questionnaires over the course of 16 weeks. Safety and efficacy assessments will be performed 2, 4, 8, 12, 14 and 16 weeks after baseline. Rescue medication will be provided by the study Sponsor. The primary objective is to demonstrate a clinically significant improvement in the morning Forced Expiratory Volume (FEV1) in patients who received active QAW039.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  11/NW/0608

• Date of REC Opinion

  24 Oct 2011

• REC opinion

  Further Information Favourable Opinion