NCT03019237

Effect of Intranasal Anti-IgE Antibodies on IgE Production

The Effect of Intranasal Application of Anti-IgE Antibodies on IgE Production in Patients Suffering From Seasonal Allergic Rhinitis - a Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Conditions

• Allergy

Interventions

Type	Name	Description
DRUG	anti-IgE	intranasal anti-IgE
OTHER	intranasal allergen	intranasal allergen
OTHER	intranasal saline	intranasal placebo

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2017-01-12
• Last updated: 2017-01-12

Locations

1 site across 1 country: Austria