Wilmott 1996.
| Methods | Randomised double‐blind trial. Parallel design. Duration: 15 days during a respiratory exacerbation. Measurements taken on days 1, 8 and 15. |
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| Participants | 80 participants admitted to hospital for at least 1 night for treatment of a chest exacerbation (protocol defined) with FVC > 35% predicted. CF was diagnosed on genotype, sweat test. Age: over 5 years. No withdrawals mentioned in the paper. |
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| Interventions | Treatment: nebulised rhDNase 2.5 mg twice daily (n = 43) Control: nebulised placebo twice daily (n = 37). |
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| Outcomes | Mean change in % predicted FVC and FEV1, number of deaths and number experiencing an adverse event, quality of life score and dyspnoea score. | |
| Notes | Potential confounder was type of antibiotic used: 8 of 36 placebo participants received an oral antibiotic versus 8 out of the 44 in the treatment group. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Unclear. |
| Allocation concealment (selection bias) | Unclear risk | Method unclear. |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Described as double blind, no further details. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT. No withdrawals mentioned in the paper. |
| Selective reporting (reporting bias) | Unclear risk | Measurements taken on days 1, 8 and 15, no reported results, graph shown in paper. |
| Other bias | Unclear risk | Potential confounder was type of antibiotic used: 8 of 36 placebo participants received an oral antibiotic versus 8 out of the 44 in the treatment group. |
<: less than >: greater than % predicted: percent predicted CF: cystic fibrosis CFQ‐R: CF questionnaire‐revised CI: confidence interval CT: computer tomography FEF25‐75: forced expiratory flow at 25 to 75% of the FVC FEV1: forced expiratory volume at one second FVC: forced vital capacity HS: hypertonic saline ITT: intention‐to‐treat IV: intravenous LCI: lung clearance index PFT: pulmonary function test rhDNase: recombinant human deoxyribonuclease RV: residual volume SD: standard deviation TLC: total lung capacity