Effect of Intranasal Anti-IgE Antibodies on IgE Production

Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03019237
• Other study ID #: 2012-004193-25
• Status: Completed
• Phase: N/A
• First received: January 10, 2017
• Last updated: January 10, 2017
• Start date: November 2012
• Est. completion date: May 2013

Study information

• Verified date: January 2017
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyAustria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Allergy

Intervention

Drug:
• anti-IgE
intranasal anti-IgE

Other:
• intranasal allergen
intranasal allergen
• intranasal saline
intranasal placebo

Locations

Country	Name	City	State
Austria	Dept. of Otorhinolaryngology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of allergen-specific IgE		8 weeks	No
Secondary	changes in total IgE		8 weeks	No