The effect of Omalizumab in non-atopic asthma -(version1- 11/03/09)

• Research type

  Research Study

• Full title

  The effect of a humanised monoclonal anti-IgE antibody (omalizumab) on disease control and bronchial mucosal inflammation in non-atopic (“intrinsic”) asthma

• IRAS ID

  11056

• Contact name

  Chris Corrigan

• Sponsor organisation

  King's College,London

• Eudract number

  2009-009154-25

• Research summary

  Bronchial asthma is one leading cause of suffering, affecting over 3.5 million adults, and more children. On average there is one hospital admission for asthma every 7 minutes and one death every 7 hours. Asthma is estimated to cost the UK in the region of 2.3 billion pounds annually. Despite taking existing drugs, many asthmatics suffer regular, sudden severe attacks which make their lives a misery. These patients need new treatments urgently. Based on the reactions to common allergens (pollens, dust, animal dander and moulds) asthmatics are classified into two groups such as allergic (atopic) and non-allergic (non-atopic) asthmatics. Immunoglobulin E (IgE) is a protein in our body which plays a major role in allergic reactions and asthma. A new treatment called anti-IgE or omalizumab has recently become available for patients who have unexpected attacks of severe asthma. Omalizumab combines with IgE, making it unavailable to initiate an asthmatic attack. However, at present omalizumab is licensed to be used only in ??allergic" asthmatics, thus excluding about 30% of the total severe asthmatic population. We have very good reason to believe that omalizumab will also help non-allergic asthmatics, and this study is aimed at showing this. If we are right then many thousand more asthmatics will benefit from omalizumab treatment. We are currently recruiting adult non-allergic asthmatic patients into the study. Those who satisfy the inclusion and exclusion criteria will undergo assessment of baseline lung function and keep records of their symptoms and peak flows. They will receive omalizumab or placebo (dummy) injections at regular intervals until the end of the trial. Assessments will be repeated at the end of the trial to check for any improvement. We will also collect samples from the breathing tubes by a technique called bronchoscopy (a camera test) before and after treatment with omalizumab. A participant will remain in the study for 22 weeks.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  09/H0804/43

• Date of REC Opinion

  22 Jun 2009

• REC opinion

  Further Information Favourable Opinion