NCT03019237

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

January 10, 2017

Last Update Submit

January 10, 2017

Conditions

Allergy

Outcome Measures

Primary Outcomes (1)

  • change of allergen-specific IgE

    8 weeks

Secondary Outcomes (1)

  • changes in total IgE

    8 weeks

Study Arms (3)

intranasal anti-IgE

EXPERIMENTAL

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 allergen

ACTIVE COMPARATOR

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 saline

PLACEBO COMPARATOR

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

Interventions

anti-IgEDRUG

intranasal anti-IgE

Also known as: Omalizumab
intranasal anti-IgE
intranasal allergenOTHER

intranasal allergen

Also known as: GMP produced recombinant Bet v 1
intranasal allergen
intranasal salineOTHER

intranasal placebo

Also known as: sodium chloride 0.9%
intranasal saline

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • birch pollen allergy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Otorhinolaryngology, Medical University of Vienna

Vienna, A-1090, Austria

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

anti-IgE antibodiesOmalizumabSodium Chloride

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-IdiotypicAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalSerum GlobulinsGlobulinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Verena Niederberger, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ao. Univ.-Prof. Dr.

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 12, 2017

Study Start

November 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

January 12, 2017

Record last verified: 2017-01

Locations

AU(1)