Nenna 2017.
Methods | Double‐blind RCT. Cross‐over design. Duration: 16 weeks in each treatment arm; total duration 32 weeks. Single centre in Italy. |
Participants |
Inclusion criteria: aged 4 ‐ 6 years; diagnosed with CF; clinically stable; undergoing a simple therapy based on bronchodilators and physiotherapy; no respiratory infections during the treatment or 2 weeks before. Exclusion criteria: children with instable medical conditions 12 participants randomised. Age, mean (SD): 5.7 (0.8) years. Gender split: 6 males, 6 females. |
Interventions |
Intervention: 4 mL HS (7%) inhaled 2x daily. Control: 4 mL IS (0.9%) inhaled 2x daily. There is no washout period between the 2 treatments, and children are followed up after 4, 16, 20 and 32 weeks. |
Outcomes |
Primary outcomes Airways resistance measured using interrupter resistance technique at baseline, 4, 16, 20, 32 weeks Lung function (FVC, FEV1 and FEF25‐75) measured using spirometry at baseline, 4, 16, 20, 32 weeks Secondary outcomes Side effects measured using a standardized questionnaire created for the purpose of this study throughout the 31 week study period by healthcare providers. |
Notes | Results published in 2017 (www.ncbi.nlm.nih.gov/pubmed/28709466). |