Fuchs 1994.
Methods | Randomised, double‐blind trial. Parallel design with 3 arms. Duration: 24 weeks. Measurements were taken on days 7, 14 and every 14 days thereafter. |
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Participants | 968 participants randomised, diagnosed CF on genotype, sweat test or clinically. Age: over 5 years. More participants aged 17 ‐ 23 years were in the once daily rhDNase arm. Disease status: FVC > 40 % predicted and clinically stable. 25 people withdrew from the trial, 8 in the placebo group and once‐daily group and 9 in the twice‐daily group. |
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Interventions | Treatment 1: nebulised rhDNase 2.5 mg once daily (n = 322). Treatment 2: nebulised rhDNase 2.5 mg twice daily (n = 321). Control: placebo (n = 325). |
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Outcomes | Outcomes included in this review: mean % change in FVC and FEV1, number of participants needing IV antibiotics for at least 1 chest exacerbation (protocol defined), mean number of days IV antibiotics used, mean number of days as an inpatient, number of deaths and number experiencing an adverse event. Not included in this review: CF symptom score, dyspnoea score. Cost of treatment is reported by von der Schulenberg (1995), Oster (1995) and Menzin (1996). |
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Notes | ||
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 | Described as double blind, no further details. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT principle was used. 25 participants withdrew from the trial, 8 in the placebo group and once‐daily group and 9 in the twice‐daily group. |
Selective reporting (reporting bias) | Unclear risk | Measurements were taken on days 7, 14 and every 14 days thereafter. The published trial reported the end of trial results only. |
Other bias | Low risk | None identified. |