Robinson 2005.
Methods | Randomised double‐blind, placebo‐controlled trial. Parallel design. Duration: 1 year. Participants evaluated at 3 months and 1 year. |
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Participants | 25 children randomised. Age: range 6 ‐ 18 years old. Disease status: normal or mildly reduced lung function (FVC ≥ 85%, FEV1 > ˜70%). There were 4 withdrawals, all were for non‐trial drug‐related reasons. |
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Interventions | Treatment: rhDNase 2.5 mg once daily. Control: normal saline aerosol once daily. |
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Outcomes | Included in this review: FEV1(% predicted), FVC (% predicted). Not included in this review: FEF25‐75, high resolution CT scores, composite score including high resolution CT and PFT data. |
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Notes | Measurements were taken at 3 and 12 months. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Stated as randomised but no method was described. |
Allocation concealment (selection bias) | Unclear risk | Method unclear. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double blinded (investigators, participants blinded to treatments until trial end). |
Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT analysis used. 4 withdrawals, all were for non‐trial drug‐related reasons. |
Selective reporting (reporting bias) | Low risk | None identified. |
Other bias | Low risk | None identified. |