Effect of Intranasal Anti-IgE Antibodies on IgE Production

January 10, 2017 updated by: Verena Niederberger-Leppin, Medical University of Vienna

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1090
        • Dept. of Otorhinolaryngology, Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intranasal 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.
Drug: anti-IgE
intranasal anti-IgE
Other Names:
  • Omalizumab
Active Comparator: 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.
Other: intranasal allergen
intranasal allergen
Other Names:
  • GMP produced recombinant Bet v 1
Placebo Comparator: 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.
Other: intranasal saline
intranasal placebo
Other Names:
  • sodium chloride 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of allergen-specific IgE
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in total IgE
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Verena Niederberger, MD, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

January 10, 2017

First Submitted That Met QC Criteria

January 10, 2017

First Posted (Estimate)

January 12, 2017

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-004193-25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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