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Completed

NCT Number: NCT03019237

Effect of Intranasal Anti-IgE Antibodies on IgE Production

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.

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Key information

Conditions

Allergy Hypersensitivity Immune System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Otorhinolaryngology, Medical University of Vienna

Vienna, A-1090, Austria

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

birch pollen allergy

Exclusion criteria

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

Treatment and study plan

anti-IgE

Drug

intranasal anti-IgE

Other names: Omalizumab

intranasal allergen

Other

intranasal allergen

Other names: GMP produced recombinant Bet v 1

intranasal saline

Other

intranasal placebo

Other names: sodium chloride 0.9%

Primary outcomes

  1. change of allergen-specific IgE

    Time frame: 8 weeks

Secondary outcomes

  1. changes in total IgE

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 12, 2017
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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