Clinical Trial: Effect of OC000459 on Eosinophilic Airway Inflammation in Severe Asthma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Effect of OC000459 on Eosinophilic Airway Inflammation and Asthma Control in Subjects With Refractory Eosinophilic Asthma: a Randomised, Double-blind, Placebo Controll

Brief Summary: The aim is to study the effect of OC000459 on eosinophilic airway inflammation and asthma control in subjects with severe, refractory eosinophilic asthma.

Detailed Summary: At week 12 subjects not on oral corticosteroids (OCS) will complete the treatment period and return after 4 weeks for final follow up visit. Those subjects who were taking OCS at baseline will continue for a maximum of 12 additional weeks, double blind period during which their current OCS treatment will be titrated down according to their clinical response.
Sponsor: Atopix Therapeutics, Ltd.

Current Primary Outcome: Compare the effect of OC000459 50mg given once daily with placebo on the induced sputum eosinophil counts. [ Time Frame: Mean change from baseline and week 12 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The effect on pre- and post-bronchodilator spirometry using forced expiratory volume in one second (FEV1). [ Time Frame: Every 4 weeks up to week 12 ]
  • The effect of OC000459 on fractional exhaled nitric oxide (FeNO). [ Time Frame: At 4,8 and 12 weeks ]
  • Measuring quality of life using standardised asthma quality of life questionnaire (AQLQ(S)). [ Time Frame: At weeks 4,8 and 12 ]
  • Statistical comparison from baseline on induced sputum eosinophil count. [ Time Frame: At weeks 4,8 and 12 ]


Original Secondary Outcome: Same as current

Information By: Atopix Therapeutics, Ltd.

Dates:
Date Received: September 4, 2015
Date Started: September 2016
Date Completion: September 2017
Last Updated: October 3, 2016
Last Verified: October 2016