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. 2018 Sep 6;2018(9):CD001127. doi: 10.1002/14651858.CD001127.pub4

Suri 2001.

Methods Open randomised controlled trial.
Cross‐over design.
Duration: 3 treatment periods of 12 weeks with a 2‐week wash out period between each period. Measurements were taken at the start and end of each 12‐week period.
Participants 48 children randomised, 45 completed first treatment period, 44 completed the second treatment period and 40 completed the third treatment period.
Age: range 7.3 ‐ 17 years.
Interventions Treatment 1: 2.5 mg rhDNase once daily.
Treatment 2: alternate day 2.5 mg rhDNase.
Treatment 3: 5 mL 7% HS twice daily.
Outcomes Primary outcome was FEV1; secondary outcomes were FVC, number of pulmonary exacerbations, weight gain, quality of life, exercise tolerance and the total costs of hospital and community care.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Block randomisation was used.
Randomisation carried out by telephone to an independent trials co‐ordinating unit, and stratified by hospital and balanced after each group of 12 children.
Allocation concealment (selection bias) Low risk Independent trials co‐ordinator.
Blinding (performance bias and detection bias) 
 All outcomes High risk Not blinded, due to the taste of the HS. Outcomes included subjective measures including quality of life therefore risk of bias considered high.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 48 children randomised, 45 completed 1st treatment period, 44 completed the 2nd treatment period and 40 completed the 3rd treatment period.
Data analysed according to ITT principle
Selective reporting (reporting bias) Low risk None identified.
Other bias Low risk Cross‐over design with washout period of 2 weeks which should be adequate for lung function to return to baseline.