Study of MEM 1414 on the allergen induced late asthmatic response v1.0

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study to Evaluate the Efficacy, Safety and Tolerability of MEM 1414 (600 mg) on the Allergen-Induced Late Asthmatic Response in Steroid-Free Subjects with Mild Allergic Asthma

• IRAS ID

  9075

• Contact name

  Brian O'Connor

• Sponsor organisation

  Memory Pharmaceuticals Corp

• Eudract number

  2008-005910-37

• ISRCTN Number

  ISRCTN

• Clinicaltrials.gov Identifier

  NCT

• Research summary

  MEM 1414 is an experimental medicine which is given in tablet form, made by Memory Pharmaceuticals. Based on results so far, we hope that in the future it may help people with asthma. The purpose of this study is to find out if MEM 1414 has a beneficial effect in asthma in an experimental situation, and what side effects there are. Our study will include people who have mild asthma but do not take regular medication for it, and who are otherwise healthy. We will do physical, blood and allergy tests to check they are suitable for the study. Then we will ask them to take MEM 1414 (or placebo ?? tablets without any active drug) every day for a week. At the beginning and end of this treatment week they will breathe in substances which should bring on a slight asthma attack. We will measure how much air they breathe out in one second when they push the air out really hard. After a two week break, there will be a second week of treatment. The patients will get whichever treatment they did not get last time (real drug or placebo), and we will do the breathing tests again. We will compare their results before and after each treatment to find out the effect of MEM 1414. We will monitor the patients for side effects. We expect to ask up to 60 people to enter the study, expect 16 to get treatment. We believe that this number will give us a reliable result from the study. There will be two investigational sites (Heart Lung Centre in London and the Medicines Evaluation Unit in Manchester). It is unlikely that the patients?? asthma will improve as a result of this study and we will pay them for helping in our research.

• REC name

  London - Central Research Ethics Committee

• REC reference

  08/H0718/73

• Date of REC Opinion

  27 Nov 2008

• REC opinion

  Further Information Favourable Opinion