Scripps 2009.
Methods | Double‐blind, randomised, parallel‐group trial |
Participants | Inclusion criteria: aspirin‐exacerbated respiratory disease, allergic asthma Exclusion criteria: pregnant females, starting immunotherapy in the past three months, prior treatment with Xolair, negative allergy skin tests, unable to participate in lung function tests, unable to complete data forms, low platelets, serum IgE greater than 700 IU, cancer, another uncontrolled medical condition, unacceptable concomitant medication, younger than 18 years of age Protocol: '40/60 patients will receive omalizumab injections every month for the next 4 months and the other 20 patients, via a random program, will receive placebo injections' and '60 patients with aspirin‐exacerbated respiratory disease will be screened to determine if they also have allergic respiratory tract disease as a co‐morbid complication. This will involve history, allergy skin tests and a serum IgE level. They must also have been desensitised to aspirin and be taking aspirin 325 or 650 mg morning and night'. |
Interventions | Omalizumab versus placebo |
Outcomes | Primary: respiratory index score. Secondary: FEV1, nasal flow rates, nasal smell scores, quality of life scores for rhinitis and asthma |
Notes | Four‐month trial. No data available at time of completion of 2013 update of this review |