Study characteristics | ||
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Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma | A randomized, double-blind, placebo-controlled trial of anti-IgE for chronic rhinosinusitis | |
First author | Gevaert | Pinto |
Publication year | 2013 | 2010 |
Country | Belgium | USA |
Funding source | Ghent University, Flemish Scientific Research Board, Belgian Research Fund, Interuniversity Attraction Poles Program, Global Allergy and Asthma European Network, Novartis | Genentech and McHugh Research Fund, Dennis W. Jahnigen Career Development Award (American Geriatrics Society) |
Study design | RCT | RCT |
Inclusion criteria | Age ≥18 with CRSwNP, comorbid asthma for >2 years, serum IgE between 30 and 700 kU/mL | Age 18–75, >12 weeks of symptoms with confirmation on CT and nasal endoscopy, serum IgE between 30 and 700 kU/mL |
Exclusion criteria | N/A | Weight >150 kg, secondary causes of CRS, contraindications to omalizumab |
No. of subjects randomized | 24 | 14 |
No. of subjects excluded | 4 | 0 |
No. of subjects withdrawn | 1 | 0 |
No. of subjects analyzed | Total (n) = 23 | Total (n) = 14 |
Men (n) = N/A | Men (n) = 10 | |
Women (n) = N/A | Women (n) = 4 | |
Age | Mean = N/A | Mean = 45.85 |
Median = N/A | Median = N/A | |
Range = 42–56 | Range = N/A | |
Drug dose | Max dose of 375 mg | 0.016 mg/kg per IU total serum IgE/mL |
Dosing frequency | Every 2 weeks (eight injections in total); every month (four injections in total) | At enrollment and every 4 weeks for the 6 months duration |
Study duration | 20 weeks (16 weeks follow-up) | 6 months |