Effect of Intranasal Anti-IgE Antibodies on IgE Production

Not Applicable

Completed

• Conditions: Allergy
• Interventions: Drug: anti-IgE; Other: intranasal allergen; Other: intranasal saline

• Registration Number: NCT03019237
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2017-01
• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-10
• Last Update Submitted: 2017-01-10
• Study First Posted: 2017-01-12
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

birch pollen allergy

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Exclusion Criteria

history of anaphylaxis autoimmune diseases treatment with corticosteroids, antihistamines, immunosuppressant drugs, beta-blockers significant medical conditions pregnancy or lactation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intranasal anti-IgE	anti-IgE	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.
intranasal allergen	intranasal allergen	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.
intranasal saline	intranasal saline	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.

Primary Outcome Measures

Name	Time	Method
change of allergen-specific IgE	8 weeks

Secondary Outcome Measures

Name	Time	Method
changes in total IgE	8 weeks

Trial Locations

Locations (1)

Dept. of Otorhinolaryngology, Medical University of Vienna; 🇦🇹 Vienna, Austria