Haldar 2009.
Study characteristics | ||
Methods | Randomised, double‐blind, placebo‐controlled, parallel‐group study | |
Participants | 61 participants had refractory eosinophilic asthma and a history of recurrent severe exacerbations.
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Interventions | Mepolizumab IV (750 mg) vs matched placebo (150 mL of 0.9% saline) at monthly intervals for 1 year | |
Outcomes | Reported as: "[P]rimary outcome measure was the number of severe exacerbations/participant during the 50‐week treatment phase. Secondary outcomes included a change in asthma symptoms, scores on the Asthma Quality of Life Questionnaire (AQLQ, in which scores range from 1 to 7, with lower values indicating more severe impairment and a change of 0.5 unit considered to be clinically important), forced expiratory volume in 1 second (FEV1) after use of a bronchodilator, airway hyperresponsiveness, and eosinophil counts in the blood and sputum." | |
Notes | Single‐centre study conducted at Institute for Lung Health, Leicester, UK Supported by GlaxoSmithKline |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Reported as: "Stratified randomisation with use of the minimisation method, which was performed by an independent clinician. Participants were randomly assigned with the use of the minimisation method to receive 12 infusions of either 750 mg of mepolizumab delivered intravenously or matched placebo (150 mL of 0.9% saline) at monthly intervals between visits 3 and 14. The criteria used for minimisation were the frequency of exacerbations in the previous 12 months, the baseline eosinophil count in the sputum and the number of participants taking oral corticosteroids." |
Allocation concealment (selection bias) | Unclear risk | Details not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Reported as double‐blind |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Reported as double‐blind |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Reported as: "A total of 61 of the 63 participants ( one required and operation and one withdrew consent) who were screened started treatment and constituted the modified intention‐to‐treat population. Thirty‐two participants were randomly assigned to receive placebo. Overall, 94.9% of treatment visits were completed. Participants who withdrew completed a mean of 4.6 treatment visits (38.3%)." |
Selective reporting (reporting bias) | Low risk | No apparent indication of reporting bias |