Study design (if review, criteria of inclusion for studies)
Randomised, blinded, placebo-controlled, parallel-group, multicentre study
Participants
140 CF patients
Interventions
Participants were randomised to 0.9% (n=47), 3% (n=48) or 6% (n=45) saline
Outcome measures
The primary outcome was forced expiratory volume in 1â s. The secondary outcomes were: forced vital capacity (FVC) and forced expiratory flow at 25-75% of FVC; quality of life; exercise capacity; acquisition or loss of bacterial organisms in expectorated sputum; tolerability of nebulised saline; pulmonary exacerbations; and adverse events.
Main results
3% saline significantly improved lung function and increased the time to first pulmonary exacerbation compared with 0.9% saline but did not improve quality of life. 6% saline had similar benefits to 3% saline but also significantly improved quality of life compared with 3% saline. Only 6% saline delayed the time to intravenous antibiotics for pulmonary exacerbation. Tolerability and adherence were similar.
Authors' conclusions
Dilution of 6% saline to 3% maintains the benefits for lung function and exacerbation prevention; however, the positive impacts of 6% saline on quality of life and time to i.v. antibiotics for pulmonary exacerbations are lost.
Keywords: hydration; Hypertonic Solutions; Inhalation OR nebulised; nebuliser; non pharmacological intervention - devices OR physiotherapy; pharmacological_intervention; Airway clearance drugs -expectorants- mucolytic- mucociliary-; Respiratory System Agents;