Therapeutic Utility of Xolair in Patients Undergoing Aspirin Desensitization

Conditions

• Aspirin Sensitivity

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Omalizumab — DRUG
  Subjects randomized to Omalizumab prior to aspirin desensitization
• placebo — DRUG
  Subjects randomized to Placebo prior to aspirin desensitization

Study Details

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.

Key Dates

Start date

May 31, 2006

Status verified

Oct 2020

Primary completion

Feb 29, 2016

Completion

Feb 29, 2016

Study Design

Enrollment

16 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo Group
  Subjects randomized to placebo
• Active Comparator: Omalizumab Group
  Subjects randomized to omalizumab

Primary Outcome Measure

Number of Participants Without Respiratory Reaction During Aspirin Desensitization [ Time Frame: 24 weeks ]

Locations (1)

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