The Effects of Omalizumab (Anti-IgE) on the Late-phase Response to Nasal Allergen Challenge

Phase 2

Completed

• Conditions: Cat Allergy
• Interventions: Drug: Placebo; Drug: Omalizumab

• Registration Number: NCT01003301
• Lead Sponsor: Johns Hopkins University

Brief Summary

This research is being done to study the effects of the drug omalizumab (Xolair) in people with cat allergies. The investigators will use omalizumab to study changes in the cells in the nose, cells in the blood and cells in the skin that cause allergies. The investigators will compare the changes in the nose to changes in the skin and blood cells.

Objective: To test the hypothesis that treatment with omalizumab will decrease the nasal allergen challenge late-phase eosinophil count in nasal brushings at the time when blood basophils have become hypo-responsive to in vitro allergen exposure.

Detailed Description

This is a randomized, placebo-controlled, double-blind, parallel group design study that includes 3.5 months of treatment with omalizumab or placebo and a 3 month follow-up. All subjects will be cat allergic.

Twenty four subjects (1:1 randomization) will undergo a cat allergen nasal challenge prior to treatment and another challenge after 2 months of treatment or when their blood basophils become hyporesponsive to cat allergen in vitro. A second group of 10 subjects (1:1 active:placebo), will not undergo nasal challenges. This group will participate in an ancillary study in which the effects of omalizumab on gene expression profiles in peripheral blood cells will be studied.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-27
• Study First Submitted QC: 2009-10-27
• Study First Posted: 2009-10-28
• Primary Completion: 2012-12
• Study Completion: 2013-09
• Results First Submitted: 2014-01-07
• Status Verified: 2014-02
• Results First Submitted QC: 2014-02-24
• Last Update Submitted: 2014-02-24
• Results First Posted: 2014-04-07
• Last Update Posted: 2014-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

1. Asthma with baseline FEV1 < 80% predicted, and/or moderate to severe asthma classification per the 2007 NAEPP guidelines.
2. Individuals with total serum IgE levels less than 30 IU/mL or greater than 700 IU/mL at the time of enrollment.
3. Individuals with reduced hematocrit (< 32%), WBC count (2400/microliter), platelet count (< 75000/microliter), and increased creatinine (> 141.4 micromolar/L), or AST (> 100 IU/L).
4. Individuals with body weight less than 30 kg or greater than 150 kg.
5. Pregnant females or females with plans to become pregnant or breastfeed during the duration of the study.
6. Individuals with perforated nasal septum, structural nasal defects, large nasal polyps causing obstruction, evidence of acute or chronic sinusitis.
7. History of malignancy, anaphylaxis or bleeding disorder.
8. Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
9. Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
10. Use of any investigational drugs within 8 weeks of participation.
11. Contraindications to omalizumab including patients with a previous hypersensitivity to omalizumab.
12. Recent recipient of any licensed or investigational live attenuated vaccine(s) within two months of study initiation such as flu mist.
13. Any prior use of omalizumab.
14. Frequent episodes of acute sinusitis (>2 documented episodes per year) or active sinusitis within 2 weeks prior to enrollment
15. Use of aeroallergen immunotherapy within 5 years prior to enrollment
16. Current or within 4 weeks prior to enrollment use of nasal steroids, nasal cromolyn or oral steroids
17. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or may compromise the quality

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.
Omalizumab	Omalizumab	Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.

Primary Outcome Measures

Name	Time	Method
The the Size of the 8 Late-phase Skin Response	Baseline, 2-6 wks	Reduction in skin late phase size at 8 hours at the time of blood basophil hypo-responsiveness to allergen will be reduced compared to baseline.

Trial Locations

Locations (1)

Johns Hopkins Asthma and Allergy Center; 🇺🇸 Baltimore, Maryland, United States