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

Ballmann 2002.

Methods Open pilot trial.
Cross‐over design.
Duration: 2 treatment periods of 3 weeks, with a 3‐week washout period. Participants were assessed before and after each period.
Participants 14 participants (mean age 13.3 years) with mild to moderate pulmonary involvement.
 Withdrawals were not discussed within the paper.
Interventions Treatment: 2 puffs salbutamol via a spacer prior to nebulisation of 2.5 mg dornase alfa once daily.
Control: 2 puffs salbutamol via a spacer prior to nebulisation of 10 ml 5.85% HS once daily.
Outcomes Change from baseline for FEV1 (% predicted), not clear if relative or absolute change.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Described as randomised, but method not clear.
Allocation concealment (selection bias) Unclear risk Method unclear.
Blinding (performance bias and detection bias) 
 All outcomes High risk Not blinded, due to the taste of the hypertonic saline.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No discussion of whether ITT analysis performed. Withdrawals were not discussed within the paper.
Selective reporting (reporting bias) Low risk None identified.
Other bias Low risk Cross‐over design with washout period of 3 weeks which should be adequate for lung function to return to baseline.