Solèr 2001.
| Methods | Randomised, double‐blind, parallel‐group, placebo‐controlled trial. Randomisation by random number sequences. Participants randomly assigned at visit three. Independent personnel were responsible for allocation | |
| Participants | N = 546 (1356 screened). Age range: 12 to 75, 268 male participants. Asthma diagnosed according to ATS guidelines Inclusion criteria: asthma diagnosed for longer than one year, positive skin prick test to at least one allergen, serum total IgE level > 30 and < 700 IU/mL‐1, body weight < 150 kg, baseline FEV1 > 40% and < 80% predicted, increasing by > 12% within 30 minutes of taking salbutamol, mean total daily symptom score > 3 (max 9) during 14 days before randomisation, treatment with ICS 200 mcg BDP per day for > three months before randomisation, use of beta‐agonists on an as‐needed/regular basis Exclusion criteria: unstable asthma, significant alteration to regular medication and acute exacerbation requiring additional corticosteroid treatment > one month before screening visit, oral steroids. 59 participants withdrew from the study (placebo: n = 40; omalizumab: n = 19). Reasons cited were withdrawal of consent (placebo: n = 14; omalizumab: n = 3), unsatisfactory therapeutic effect (placebo: n = 11; omalizumab: n = 8), adverse events (placebo: n = 5; omalizumab: n = 0) |
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| Interventions | Subcutaneous omalizumab ≥ 0.016 mg/kg/IgE (IU/mL) versus placebo over a core 28‐week period. Run‐in phase was four to six weeks with stabilisation of BDP. Stable and reduction phases of BDP followed randomisation. Trial extension phase lasted 32 weeks | |
| Outcomes | Number of exacerbations, change in serum free IgE, reduction in BDP, symptom score, rescue medication use, morning PEF, safety and tolerability | |
| Notes | Jadad score: 5 Trial 009 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation by random number sequences. Participants randomly assigned at visit three |
| Allocation concealment (selection bias) | Low risk | Independent personnel responsible for allocation |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 20 participants 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 |