Allergen challenge Phase IIa Study

• Research type

  Research Study

• Full title

  A phase IIa single-centre, randomised, double-blind, placebo-controlled, two-way cross-over allergen challenge study to evaluate the effect of treatment with once daily AQX-1125 on the late asthmatic response (LAR) to Inhaled Allergen Challenge (IAC) in subjects with mild to moderate atopic asthma.

• IRAS ID

  86239

• Contact name

  Brian Leaker

• Sponsor organisation

  Aquinox Pharmaceuticals Inc

• Eudract number

  2011-003012-23

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  AQX-1125 is an experimental oral drug made by Aquinox Pharmaceuticals Inc. The purpose of the study is to assess the effect of AQX-1125 in mild to moderate asthmatics on lung function, inflammation of airways and the early and late asthmatic responses after inhalation of an allergen. Early asthmatic response is when lung function drops with the onset of asthma symptoms following inhalation of an allergen, followed by a recovery period. Late asthmatic response occurs between 4-10 hours after inhalation of the allergen when asthma symptoms reappear.The study will also assess the safety of AQX-1125 in mild to moderate asthmatics. Non smoking asthmatic subjects aged 18-55 years of age who only use a short acting bronchodilator (reliever inhaler) and are otherwise healthy will be included. Both male and female subjects must be willing to use contraception for the duration of the study and for 3 months after. There will be two screens. Eligible subjects will complete two treatment periods, which are 7 days long each. Each treatment period is separated by a 14-21 day washout period (time during which subjects do not take the drug/placebo). Subjects will atttend the centre on days 1 and 6 of each treatment period. On day 6, they will stay overnight and will be discharged home on day 7 after some assessments and tests. Subjects will be instructed to take the drug at home on days 2-5. A follow up visit will be conducted 14 days ( 3 days) after day 7 of treatment period 2. Side effects of the study drug will be monitored throughout the study. 22 subjects will be entered onto the study in order to have 20 evaluable (completed) patients.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  11/LO/1379

• Date of REC Opinion

  10 Oct 2011

• REC opinion

  Further Information Favourable Opinion