San Miguel Pagola 2016.

Study characteristics
Methods	RCT. Cross‐over design (2 arms, 1‐week washout). Location: 7 Spanish Centres Duration: 17 days in total, each arm 5 days with a 1‐week washout.
Participants	22 participants. Confirmed diagnosis of Cystic Fibrosis by sweat test or genetics. >16years of age . Able to expectorate>10mls of sputum per day on 2 different days. Clinically stable and able to nebulise independently.
Interventions	Intervention: participants inhaled 7% hypertonic saline + 0.1% hyaluronic acid (for 20 minutes) combined with an OPEP device (Acapella Duet) then following this performed their usual session of AD for 30 minutes. Control: usual care, participants inhaled 7% hypertonic saline + 0.1% hyaluronic acid (for 10 minutes) then following this performed their usual session of AD for 20 minutes. During the trial period the participants' pharmacological treatment remained unchanged. Patients carried out the nebulisation and treatment at home for 5 consecutive days in each arm.
Outcomes	Wet sputum production (mL) 2 hours after chest physiotherapy session. Wet sputum production (mL) 22 hours after chest physiotherapy session. Lung function at 5 days (FEV1, FVC, FEF25-75). Safety and tolerability of session (pulse‐oximetry, heart rate, dyspnoea, haemoptysis, cough, throat irritability and saltiness, heart rate) after 45 minutes. Participant perception (Likert test) at 5 days. Leicester Cough Questionnaire and Cough and Sputum Questionnaire at 5 days.
Notes	32 participants were screened and 22 met the inclusion criteria for inclusion into the study
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation.
Allocation concealment (selection bias)	Low risk	Concealed allocation‐ opaque envelopes.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Paper reports blinded assessors, however it is unclear who is assessing what result. Participants could not be blinded to the activity as they were using an additional device and the physiotherapists were assessing quality of treatmetn carried out based on video material therefore it would not be possible to blind them to the device use.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No drop outs identified
Selective reporting (reporting bias)	Unclear risk	Not discussed, although participants are self‐administering and self‐reporting and there is some concern that this could influence results and there appears to be no measures in place to limit this possibility.
Other bias	Unclear risk	Not identified