To Assess the Effect of RNS60 and Budesonide in Asthmatic Patients

• Research type

  Research Study

• Full title

  A Phase IIA randomized, double-blind, placebo controlled, cross-over study to evaluate the effects of multiple doses of inhaled RNS60 and Budesonide on the late phase asthmatic response to allergen challenge in patients with mild asthma

• IRAS ID

  165720

• Contact name

  Ronnie Beboso

• Contact email

  ronnie.beboso@quintiles.com

• Sponsor organisation

  Revalesio Corporation

• Eudract number

  2014-003846-29

• Duration of Study in the UK

  0 years, 11 months, 2 days

• Research summary

  Asthma afflicts over 300 million people worldwide. It has no cure. Many people still die from asthma every year. Its current treatments have side effects, and can be harmful. New, more effective treatments for asthma are therefore required.
  
  RNS60 is intended for use as additional treatment for asthma that would enable asthmatics to use a lower dose of inhaled steroids. It consists of oxygen dissolved in medical grade saline. The solution has undergone special treatment which makes each individual oxygen molecule to be surrounded by a layer of ions.
  
  About 18 male and female patients with mild asthma, who only require a reliever, will be studied in 3 periods. They will receive either RNS60, inhaled steroid (budesonide) or control (salty water) in each period. The patients’ response to allergen challenge, measured with lung function tests (blowing into a machine) will be used to compare the effect of receiving treatment for 21 days. The response to allergen will be assessed before, and after each 21 days of treatment. The 3 treatment periods will be separated by at least 21 days. Because it is not certain how long the effect of RNS60 will last, the first 12 patients enrolled will receive either RNS60 or saline in the first period. Their response to allergen will then be assessed immediately after 21 days of treatment, and again 21 days later. If there is any suggestion that the effect of RNS60 hasn’t worn off, they will be assessed again 21 days later. If it turns out that the effect of RNS60 lasts for more than 21 days, the time between treatment periods will be adjusted so that the effect would wear off before each patient proceeds from one period to the next.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  14/LO/1974

• Date of REC Opinion

  20 Jan 2015

• REC opinion

  Further Information Favourable Opinion