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

Amin 2010.

Study characteristics
Methods RCT.
Design: cross‐over trial with 4 weeks treatment in each arm and 4‐week washout period.
Location: Canada (multicentre).
Participants Total participants: n = 20 randomised, 1 excluded from analysis. 7 males and 12 females.
CF diagnosis as defined by two or more clinical features of CF and a documented sweat chloride > 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterised disease causing mutations.
Mean (SD) age at baseline = 10.6 (3.1) years.
Baseline characteristics
Pseudomonas aeruginosa +ve: n = 7
BMI: mean (SD) 17.0 (3.0)
Pancreatic insufficiency: 84%
Genotype
DF508/DF508 homozygous: 42%
DF508 compound heterozygous: 21%
Lung function:

  1. FVC % predicted: mean (SD) 101 (11.3), range (81 to 121)

  2. FEV1 % predicted: mean (SD) 96 (12), range (80 to 118)

  3. FEF25‐75% predicted: mean (SD) 84 (24), range (53 to 120)
Interventions Group 1: 4 mL HS 7% 2x daily.
Group 2: 4 mL IS 0.9% 2x daily.
The solutions were administered using the PARI LC Star nebuliser. 2x 100 mg puffs of salbutamol (Ventolin) were administered before each inhalation of study solution using a holding chamber.
Outcomes LCI, CFQ‐R (Quittner 2009), FEV1, FVC, FEF 25-75.
Notes Investigators calculated the sample size required for testing using HS as the main exposure variable and the LCI as the primary outcome variable.
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 concealed as performed by a research pharmacist not otherwise involved in the trial.
Blinding of participants and personnel (performance bias)
All outcomes High risk The solutions were indistinguishable from each other in appearance but participants could discern a difference in taste between solutions. High risk with this cross‐over design.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Blinding of researchers.
Incomplete outcome data (attrition bias)
All outcomes Low risk 20 recruited, details of missing data for 3 participants described (below), complete cross‐over data were therefore available for 17 participants.
The LCI results of 1 participant failed to meet the quality control criteria for all 4 trial visits and were therefore excluded from the analysis.
1 participant receiving IS withdrew from the trial after completion of the initial 4‐week trial period because of difficulties complying with the trial protocol.
1 participant had uninterpretable LCI data at visit 2.
Selective reporting (reporting bias) Low risk All outcomes stated in the 'Methods' section reported in the 'Results' section.
Other bias Low risk 4‐week washout period.
Investigators calculated the sample size.