Dwyer 2013.

Methods	RCT. Parallel design. Duration: 16 weeks. Location: Australia. Sequence generation: random number generation with block allocation. Treatment allocation is stratified for: age, gender, FEV1. Allocation concealment: random allocation to 1 of 3 groups by the Trial Pharmacist at the trial co‐ordinating centre. Treatment allocation recorded at the Trial Pharmacy and the random allocation lists, randomisation procedure and the unblinded treatment allocation is to be concealed from all other trial staff and the participant. Blinded.
Participants	Inclusion criteria: informed consent, diagnosis of CF (positive sweat test or genotyping), best FEV1 in the previous six months > 20% of predicted normal value FEV1 > 85% of best in the previous 6 months, no non‐routine antibiotics in the last 14 days, minimum age 6 years, both genders eligible. Exclusion criteria: colonisation with Burkholderia cepacia, major haemoptysis within the last 12 months, pregnant or lactating females, investigational drugs within the last 30 days, previous lung transplant, hypertonic saline within the last 14 days, inhaled mannitol within the last 14 days.
Interventions	Intervention 1: 2x daily inhalation of 4 mL of nebulised 6% HS + 0.25 mg/mL quinine sulphate. Intervention 2: 2x daily inhalation of 4 mL of nebulised 3% HS + 0.25 mg/mL quinine sulphate. Control: 2x daily inhalation of 4 mL of nebulised 0.9% IS + 0.25mg/mL quinine sulphate.
Outcomes	Primary outcome Lung function as measured by the change in FEV1 % predicted (measured at baseline, Week 1, Week 4, Week 8 and Week 16 (end of trial)). Secondary outcomes Lung function as measured by the change in FVC % predicted (measured at baseline, Week 1, Week 4, Week 8 and Week 16 (end of trial)). Lung function as measured by the change in FEF25‐75 % predicted (measured at baseline, Week 1, Week 4, Week 8 and Week 16 (end of trial)). QoL as measured by the Cystic Fibrosis Questionnaire‐Revised (CFQ‐R) (measured at baseline, Week 1, Week 4, Week 8 and Week 16 (end of trial)). QoL as measured by the Medical Outcomes Survey Short Form‐36 (SF‐36) (measured at baseline, Week 1, Week 4, Week 8 and Week 16 (end of trial)). Exercise capacity as measured by the total distance covered in the Modified Shuttle Test‐25 (MST‐25) (measured at baseline, Week 4 and Week 16 (end of trial)) Exercise capacity as measured by the total exercise time in the Endurance Shuttle Test‐25 (EST‐25) (measured at baseline, Week 4 and Week 16 (end of trial)). Sputum bacterial diversity as measured by the acquisition or loss of bacterial organisms in expectorated sputum as measured by routine microscopy culture and sensitivity (M/C/S) (measured at baseline and Week 16 (end of trial)). Tolerability of nebulised trial solution as measured by participant on a 10‐point visual analogue scale (measured at baseline, Week 1, Week 4, Week 8 and Week 16 (end of trial)). Medication use as measured by number of doses of each prescribed medication (measured at baseline and weekly during trial (Week 1 to Week 16)). Pulmonary exacerbations as measured by the Fuchs exacerbation criteria (measured weekly during trial (Week 1 to Week 16)). Adverse events (such as intolerable cough, sore throat, bronchospasm, haemoptysis, nausea, pulmonary exacerbation) as measured by presence of new symptoms, likelihood of being related to trial solution, severity of symptoms and time to resolution of symptoms (measured weekly during trial (Week 1 to Week 16)). Adherence to nebulisation of trial solution as measured weekly by self‐report in patient diary and count of returned unused ampoules of trial solution at the end of the trial (week 16) Administration time of nebulised trial solution as measured by stop watch from start to completion of 1 dose of trial inhalation solution (measured at baseline, Week 1, Week 4, Week 8 and Week 16 (end of trial)).
Notes	Saline at lower tonicity in cystic fibrosis (SALTI‐CF) trial. Funding source: Australian Cystic Fibrosis Research Trust.