Chanez 2010.

Methods	Randomised, double‐blind, placebo‐controlled study
Participants	Treatment group: 20 (17 completed). Age: 45.7 ± 13.30. Males: 6 (30%). Baseline lung function: mean % predicted FEV1 (SD): 61.3 (14.83) Control group: 11 (8 completed). Age: 50.6 ± 16.31. Males: 6 (54.5%). Baseline lung function: mean % predicted FEV1 (SD): 66.6 (11.38) Inclusion criteria stated as: adults aged ≥ 18 years; participants with severe persistent allergic asthma with the following characteristics: FEV1 < 80% of predicted; frequent daily symptoms (≥ four days/wk on average) or nocturnal awakening (≥ one/wk on average); multiple severe asthma exacerbations: either ≥ two severe asthma exacerbations requiring an unscheduled medical intervention with systemic corticosteroid in the past year, or hospitalisation (including emergency room treatment) for an asthma exacerbation in the past year, despite a high‐dose inhaled corticosteroid > 1000 mg beclomethasone dipropionate or equivalent and inhaled long‐acting beta2‐agonist; an allergy to a perennial allergen demonstrated with convincing criteria (i.e. positive prick skin test or in vitro reactivity to a perennial aeroallergen (RAST)); total serum IgE level ≥ 30 to ≤ 700 IU/mL and suitable serum total IgE level; weight according to Xolair dosing tablets Exclusion criteria stated as: age < 18 years; smoking history > 20 pack‐years; asthma exacerbation during the four weeks before randomisation; history of food‐ or drug‐related severe anaphylactoid or anaphylactic reaction; elevated serum IgE levels for reasons other than allergy (e.g. parasite infections, hyperimmunoglobulin E syndrome, Wiskott‐Aldrich Syndrome, allergic bronchopulmonary aspergillosis); patients with active cancer, suspicion of cancer or any history of cancer; pregnant women; known hypersensitivity to omalizumab or to one of its components; previous treatment with omalizumab (indeed previous treatment with omalizumab could have modified the FceRI expression); participated in a clinical trial in the past three months Location(s): France
Interventions	Omalizumab injected subcutaneously every two weeks or every four weeks for 16 weeks (dose and dosing interval determined on the basis of participant body weight and pretreatment serum IgE level) versus placebo Background inhaled corticosteroid dose: at least 1000 mcg beclomethasone dipropionate or equivalent daily. Mean dose/d 3556 mcg ± 1157.8 BDP equivalent/d Participants receiving maintenance OCS at baseline = 7 (22%)
Outcomes	Primary outcome measures stated as: change (%) from baseline in FcϵRI (high‐affinity IgE receptor) expression on blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo (time frame: baseline and week 16); change (%) from baseline in mean fluorescence intensity of FcϵRI after 16 weeks of treatment with omalizumab as compared with placebo (time frame: baseline and week 16) Secondary outcome measures stated as: change (%) from baseline in percent of basophils and dendritic cells expressing FcϵRI after 4, 8, 12 and 16 weeks of treatment (time frame: baseline, weeks 4, 8, 12 and 16); change (%) from baseline in mean fluorescence intensity of FcϵRI after 4, 8, 12 and 16 weeks of treatment (time frame: baseline, weeks 4, 8, 12 and 16); change from baseline in the number of days with asthma symptoms per week (time frame: baseline (four‐week screening period before randomisation) and end of study (weeks 12 to 16)); change from baseline in the number of puffs of rescue medication per week (time frame: baseline (four‐week screening period before randomisation) and end of study (weeks 12 to 16)); change from baseline in the number of nights with awakenings per week (time frame: baseline (four‐week screening period before randomisation) and end of study (weeks 12 to 16)); change from baseline in the number of days with impairment in daily activities per week (time frame: baseline (four‐week screening period before randomisation) and end of study (weeks 12 to 16)); change from baseline in the number of days with absence from school or work due to asthma symptoms (time frame: baseline (four‐week screening period before randomisation) and end of study (weeks 12 to 16)); change from baseline in the number of days with hospitalisations (time frame: baseline (four‐week screening period before randomisation) and end of study (weeks 12 to 16)); change from baseline in the number of unscheduled clinic visits (time frame: baseline (four‐week screening period before randomisation) and end of study (weeks 12 to 16)); change from baseline in morning daily peak expiratory flow (PEF) (time frame: baseline (four‐week screening period before randomisation) and end of study (weeks 12 to 16)); physician's overall assessment of treatment effectiveness (time frame: after 16 weeks of treatment)
Notes	16‐Week trial Co‐medication: steroids and LABA (all), oral corticosteroids three and four, theophylline one and one, montelukast eight and four, anticholinergics six and six
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Stratified by centre and ratio of 2:1.  Details of sequence generation not reported
Allocation concealment (selection bias)	Unclear risk	Details of allocation concealment not reported
Blinding (performance bias and detection bias) All outcomes	Low risk	Double‐blind
Incomplete outcome data (attrition bias) All outcomes	Low risk	Six participants did not complete the trial (three in each group); reasons for their withdrawal are included in trial report
Selective reporting (reporting bias)	Unclear risk	No apparent indication of reporting bias