Allergic asthma and or rhinitis due to allergy to cat dander
Conditions
Interventions
Trade Name: Xolair 150 mg powder and solvent for solution for injection
Product Name: Xolair
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: omalizumab
Current Sponsor code
Sponsors
S.G.O. Johansson, MD PhD Professor
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Sweden
Outcome results
None listed