Amin 2011.
| Methods | Randomised, placebo‐controlled trial. Cross‐over design. Duration: 4 weeks of treatment followed by a 4‐week washout before switching to alternate treatment. Single centre. |
|
| Participants | 19 randomised, 17 participants (11 females, 8 males) completed. Age 6 ‐ 18 years old; mean (SD) age 10.3 (3.4) years. |
|
| Interventions | Treatment: nebulised rhDNase 2.5 mg administered once daily via the PARI LC1 Star® nebuliser. Control: placebo administered once daily via the PARI LC1 Star® nebuliser. |
|
| Outcomes | Included in this review: LCI, FEV1 (% predicted, z score), FVC (% predicted, z score), CFQ‐R respiratory and parent respiratory domain, adverse events, exacerbations. Not included in this review: FEF25‐75. | |
| Notes | Visits occurred at 0, 4, 8 and 12 weeks after randomisation. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Concealed computer‐generated randomisation. |
| Allocation concealment (selection bias) | Low risk | Randomisation performed by a research pharmacist not otherwise involved in the trial. |
| Blinding (performance bias and detection bias) All outcomes | Low risk | All participants (solutions indistinguishable from each other), clinicians and outcome assessors blinded to treatment assignment. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Reported that data analysed according to the intention‐to‐treat principle, however, data only reported on 17 who completed trial compared to the 19 that were randomised. Missing data from 2 participants: the LCI results of 1 participant failed to meet the quality control criteria for 1 of the 4 trial visits; 1 other participant dropped out of the trial after 2 visits because of a pulmonary exacerbation requiring IV antibiotics (protocol identified reason for withdrawal from trial), but not clear what treatment the participant had completed before withdrawal. |
| Selective reporting (reporting bias) | Low risk | All outcomes reported. |
| Other bias | Low risk | Cross‐over design with washout period of 4 weeks which should be adequate for lung function to return to baseline. |