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Effect of Intranasal Anti-IgE Antibodies on IgE Production

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT03019237
Collaborator
(none)
15
Enrollment
1
Location
3
Arms
5.9
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
The Effect of Intranasal Application of Anti-IgE Antibodies on IgE Production in Patients Suffering From Seasonal Allergic Rhinitis - a Pilot Study
Study Start Date :
Nov 1, 2012
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
May 1, 2013

Arms and Interventions

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%

    		•

    Outcome Measures

    Primary Outcome Measures

    1. change of allergen-specific IgE [8 weeks]

    Secondary Outcome Measures

    1. changes in total IgE [8 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dept. of Otorhinolaryngology, Medical University of Vienna Vienna Austria A-1090

    Sponsors and Collaborators

    • Medical University of Vienna

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Verena Niederberger-Leppin, ao. Univ.-Prof. Dr., Medical University of Vienna
    ClinicalTrials.gov Identifier:
    NCT03019237
    Other Study ID Numbers:
    • 2012-004193-25
    First Posted:
    Jan 12, 2017
    Last Update Posted:
    Jan 12, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Omalizumab

    Study Results

    No Results Posted as of Jan 12, 2017