Importance of IgE antibody fraction size on allergen sensitivity of basophils from cat allergic patients on Xolair. A pilot study.

Conditions: Allergic asthma and or rhinitis due to allergy to cat dander

Registration Number: EUCTR2006-002771-40-SE

Lead Sponsor: S.G.O. Johansson, MD PhD Professor

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.a clinical history of allergic asthma and/or rhinitis
2.IgE –antibodies to cat
3.total serum IgE level between 30 and 700 kU/L
4.percent IgE antibodies to cat < 0.7% (Low group) or > 5.5% (High group)
5.body weights: 40-150 kg
6.adult outpatients of both sexes
7.fulfil the general criteria, e.g health, non-pregnancy, for receiving Xolair for treatment of allergic asthma
8. written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.not subject to previous or ongoing ASIT with cat dander allergen.
2.previously randomized into this or any other omalizumab study or who have received omalizumab by prescription.
3. with known hypersensitivity to any ingredients, including excipients (sucrose, histidine, polysorbate 20) of the study medication or drugs related to omalizumab (e.g.: monoclonal antibodies, polyclonal gamma globulin).

4.not be on treatment with oral corticosteroids or be judged to need such treatment during the trial.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of Xolair on allergic inflammation in 60 patients with low to moderate (30-700 kU/L) serum IgE levels, total IgE”, in relation to the IgE antibody fraction. The hypothesis to be tested is that subjects with a low percentage of IgE antibodies to cat allergen out of total IgE” will show a more pronounced decrease in basophil cat allergen sensitivity.;Secondary Objective: ;Primary end point(s): Cat allergen threshold sensitivity of subject’s basophilic granulocytes before and after Xolair treatment.

Secondary Outcome Measures