van Rensen 2009.
Methods | Randomised, double‐blind, parallel‐group, placebo‐controlled trial | |
Participants | N = 25. Mean age: unclear Inclusion criteria: mild persistent asthma |
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Interventions | Subcutaneous omalizumab versus placebo (dosing levels unclear) Study duration: 12 weeks |
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Outcomes | PC20 methacholine, sputum and allergen challenge followed by bronchoscopy at 24 hours; changes in PC20, sputum eosinophils, max fall in FEV1 during late asthmatic response (LAR), post‐allergen eosinophils (EG2) and mast cells (AA1) | |
Notes | Unpublished conference abstract. Jadad score: 2 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Details of sequence generation not included in trial report |
Allocation concealment (selection bias) | Unclear risk | Details of allocation concealment not included in trial report |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind |
Incomplete outcome data (attrition bias) All outcomes | Low risk | One participant did not complete the trial, and reasons for withdrawal are included in the trial report |
Selective reporting (reporting bias) | Unclear risk | No apparent indication of selective reporting bias |
ATS: American Thoracic Society; BDP: Beclomethasone; CS: Corticosteroid; E25/rhu‐MAb E25/Xolair/omalizumab: anti‐IgE; FEV1: forced expiratory volume in one second; HDM: House dust mite; ICS: Inhaled CS; IgE: Immunoglobulin E; LABA: Long‐acting beta‐agonists; OCS: Oral corticosteroid; PC20: Bronchial challenge; PEFR: peak flow; QoL: Quality of life; RTI: respiratory tract infection.