Lennox 2016.

Methods	RCT (phase I). Cross‐over design. Location: USA.
Participants	Inclusion criteria: aged 12 years and over; FEV1 greater than 50% predicted; able to spontaneously expectorate sputum (with or without chest physiotherapy); stable disease as defined by clinician assessment and no use of IV antibiotics in the past 4 weeks, no changes in CF‐related medications in the 4 weeks prior to study screening and SpO2 < 94% on room air or use of supplemental oxygen. Exclusion criteria: reactive airway disease; use of inhaled hypertonic saline in the past 28 days; use of IV antibiotics in the past 4 weeks; changes in CF‐related medications in the 4 weeks prior to screening; SpO2 < 94% on room air or use of supplemental oxygen; presence of untreated gastroesophageal reflux disease or residual acid reflux symptoms more than 3 times per week; pregnant or nursing females. 12 participants enrolled.
Interventions	Hypertonic bicarbonate group: inhaled solution of 8.4% hypertonic bicarbonate by nebuliser. HS group: inhaled solution of 7% HS by nebuliser.
Outcomes	Primary outcomes: change in exhaled breath condensate pH at 4 hours; change in pH after inhalation of 2 doses on 1 day. Secondary outcomes: change in expectorated sputum at 4 hours; change in sputum wet‐to‐dry ratio after inhalation of 2 doses on 1 day; change in spirometry at 4 hours; FEV1 before and after inhalation of 2 doses on 1 day.
Notes	Principal Investigator: Joseph M PIlewski, MD, University of Pittsburgh. Collaborators: Cystic Fibrosis Foundation Therapeutics. Start date: August 2014. Completion date: July 2016. Listed retrospectively on clinicaltrials.gov in 2018. No publication to date.