Status:
COMPLETED
The Effects of Omalizumab (Anti-IgE) on the Late-phase Response to Nasal Allergen Challenge
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Genentech, Inc.
Conditions:
Cat Allergy
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
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...
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 a...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male or female, ages 18-50
- Females must be surgically sterile or postmenopausal or using a specified acceptable form of birth control throughout the duration of the study. Females in certain categories (not sexually active, vasectomized partner) will be admitted at the discretion of the investigator on a case-by-case basis.
- Females must have a negative urine pregnancy test at Visit A and other visits specified in this protocol.
- Clinical history of perennial allergic rhinitis for at least two years, with or without seasonal allergic rhinitis, and with or without mild persistent asthma as define by the 2007 NAEPP guidelines.
- Allergic cat sensitization defined by a positive puncture skin test (mean wheal diameter 3 mm or more greater than diluent control), and a positive CAP-RAST to cat \> 0.35 kU/L.
- Positive intranasal cat allergen challenge defined by the induction of a total of ≥ 5 sneezes at screening(criterion not applicable in the ancillary study).
- Baseline in vitro histamine release of peripheral blood basophils to cat allergen ≥7%.
- Peripheral blood basophils \> two million per 100 ml of blood (criterion only applicable in the ancillary study)
- Exclusion Criteria:
- Asthma with baseline FEV1 \< 80% predicted, and/or moderate to severe asthma classification per the 2007 NAEPP guidelines.
- Individuals with total serum IgE levels less than 30 IU/mL or greater than 700 IU/mL at the time of enrollment.
- 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).
- Individuals with body weight less than 30 kg or greater than 150 kg.
- Pregnant females or females with plans to become pregnant or breastfeed during the duration of the study.
- Individuals with perforated nasal septum, structural nasal defects, large nasal polyps causing obstruction, evidence of acute or chronic sinusitis.
- History of malignancy, anaphylaxis or bleeding disorder.
- 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.
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
- Use of any investigational drugs within 8 weeks of participation.
- Contraindications to omalizumab including patients with a previous hypersensitivity to omalizumab.
- Recent recipient of any licensed or investigational live attenuated vaccine(s) within two months of study initiation such as flu mist.
- Any prior use of omalizumab.
- Frequent episodes of acute sinusitis (\>2 documented episodes per year) or active sinusitis within 2 weeks prior to enrollment
- Use of aeroallergen immunotherapy within 5 years prior to enrollment
- Current or within 4 weeks prior to enrollment use of nasal steroids, nasal cromolyn or oral steroids
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01003301
Start Date
October 1 2009
End Date
September 1 2013
Last Update
April 7 2014
Active Locations (1)
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1
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, United States, 21224