CompletedPhase 4

Therapeutic Utility of Xolair in Patients Undergoing Aspirin Desensitization

United States16 participantsStarted 2006-05

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 \< 30 IU/ml, or \> 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 cardiovascu…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants Without Respiratory Reaction During Aspirin Desensitization

Timeframe: 24 weeks

Trial details

NCT IDNCT00555971

SponsorDavid Lang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-02

Results submitted2017-04-14

View on ClinicalTrials.gov More Aspirin Sensitivity trials