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. 2023 Jun 14;2023(6):CD001506. doi: 10.1002/14651858.CD001506.pub5

Ballmann 1998.

Study characteristics
Methods RCT.
Design: cross‐over with 2 treatment periods of 3 weeks each and a washout period of 3 weeks in between.
Location: Germany.
Participants Total participants: n = 14, 8 males and 6 females.
FEV1 % predicted had to be greater than 40%.
Baseline characteristics
FEV1 % predicted: mean (SD) 75.6% (14%).
Pseudomonas aeruginosa: chronic colonisation: n = 9; free: n = 3; intermittent: n = 2.
Interventions Pre‐treated salbutamol 200 mcg MDI inhaled (2 puffs).
Group 1: 10 mL HS 5.85% 2x daily.
Group 2: 2 mL Pulmozyme 2.5 mg 2x daily.
Treatment was given via a Pari Master with Pari LL
Routine medication not altered during trial.
Outcomes Change in FEV1 as a % of predicted, nebulisation time, comparison of cost (in Deutschmarks), preference.
Notes There was a 3‐week washout between interventions.
No sample size calculation stated.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants randomised into groups of 4 and drew lots to start with HS or rhDNase.
Allocation concealment (selection bias) Unclear risk No details provided as to how lots concealed allocation.
Blinding of participants and personnel (performance bias)
All outcomes High risk Taste of HS and difference in volume made blinding not possible.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not discussed.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk No information provided whether an ITT was used.
Selective reporting (reporting bias) Low risk All outcomes stated in the 'Methods' section reported in the 'Results' section.
Other bias Low risk Washout period of 3 weeks.
No sample size calculation stated.