Phase 4 N=13 Randomized Quadruple-blind Treatment

Therapeutic Utility of Xolair in Patients Undergoing Aspirin Desensitization

Aspirin Sensitivity

Bottom Line

View on ClinicalTrials.gov: NCT00555971 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2019

Primary outcome: Primary: Number of Participants Without Respiratory Reaction During Aspirin Desensitization — 0; 5 Participants — p=0.036

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Omalizumab (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: David Lang
Primary completion: Feb 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Without Respiratory Reaction During Aspirin Desensitization	0; 5	0.036 sig
SECONDARY Measurements of Urinary LTE4 in Association With Respiratory Reaction During Aspirin Desensitization	17489; 1852	—

Summary

This is a 24 week double-blind study in which subjects will be randomized 2:1 to receive Xolair (Omalizumab) or placebo. 14 subjects will receive Xolair and 7 will receive placebo. Xolair injections will occur every 2-4 weeks. Aspirin desensitization will occur several weeks later. One month after desensitization, the final visit will occur in the GCRC. We hypothesize that administration of Xolair, a monoclonal anti-IgE antibody, prior to the aspirin desensitization will reduce severity of aspirin-induced reaction.

Eligibility Criteria

Inclusion Criteria

Age > 18 years.
Fulfill diagnostic criteria for AERD (described below), and be a candidate for aspirin desensitization chronic asthma - frequently moderate-severe or severe patients will have history compatible with variable airflow obstruction. chronic rhinosinusitis - usually requiring previous sinus surgery procedure(s). sinusitis will have been confirmed by imaging studies presently and/or in the past.

history of adverse reaction to aspirin and/or aspirin-like drugs (e.g., ibuprofen, naproxen, etc.) compatible with AERD.

Candidate for Xolair [Omalizumab] Moderate-severe persistent asthma IgE = 30-700 IU/ml IgE mediated (allergic) potential to inhalant allergen(s) by cutaneous or in vitro testing.

Exclusion Criteria

Women of childbearing potential not using appropriate contraception method(s)
Women currently breastfeeding
Women who desire to become pregnant during the time of participation in this study
Men who desire to get someone pregnant during participation in this study
Known sensitivity to Xolair [Omalizumab].
IgE level 700 IU/ml.
No evidence of atopy by immediate hypersensitivity skin testing
Use of any other investigational agent in the last 30 days
Age < 18 years.
Current tobacco habituation.
Presence of emphysema
Ethanolism or drug abuse within last 12 months.
Presence of significant medical condition including malignancy, neurologic, kidney, gastrointestinal, liver or cardiovascular disease
extensive travel commitments during the study that would interfere with study measurements or clinic visits.

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Data sourced from ClinicalTrials.gov (NCT00555971). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.