An interventional study of anti-IgE and intranasal allergen in Allergy, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-01-12.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Basic science
In this study, participants will receive either intranasal anti-IgE-antibodies (n=5) or intranasal allergen (n=5) or intranasal placebo (n=5). Blood samples will be obtained before nasal administration of study drugs and 3, 5 and 8 weeks thereafter. In the serum samples, specific and total IgE levels will be assessed.
The intranasal challenge study will be performed over 8 weeks outside of the birch pollen season (November to January) as a randomized, double blind and placebo-controlled study. During a screening visit, 15 individuals will be recruited according to eligibility criteria. They will be randomized into 3 groups (i.n. administration of anti-IgE antibodies, Bet v 1 or placebo). Intranasal administration will take place on three consecutive days and serum samples will be taken 3, 5, and 8 weeks (+/- 4 days) after the treatment for analysis of total and specific IgE levels
Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
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birch pollen allergy
Exclusion Criteria:
history of anaphylaxis autoimmune diseases treatment with corticosteroids, antihistamines, immunosuppressant drugs, beta-blockers significant medical conditions pregnancy or lactation
Anti-IgE (Xolair) will be freshly diluted in sterile 0.9% sodium chloride solution (438 μg/ml) and will be administered using a metered pump delivering 15 μl per puff to both nostrils on three consecutive days.
Drug: anti-IgE
GMP produced rBet v 1 will be freshly diluted in sterile 0.9% sodium chloride solution (50 μg/ml) and will be administered using a metered pump delivering 15 μl per puff to both nostrils on three consecutive days.
Other: intranasal allergen
Sterile 0.9% sodium chloride solution will be administered using a metered pump delivering 15 μl per puff to both nostrils on three consecutive days.
Other: intranasal saline
intranasal anti-IgE
Also known as: Omalizumab
intranasal allergen
Also known as: GMP produced recombinant Bet v 1
intranasal placebo
Also known as: sodium chloride 0.9%
change of allergen-specific IgE
Time frame: 8 weeks
changes in total IgE
Time frame: 8 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Medical University of Vienna