Tullis 2014.

Methods	RCT Conducted in 35 centres (USA: 34; Canada:1 (Feb 2010 ‐ Sept 2011)
Participants	100 participants (48 given AZLI treatment; 52 given placebo) Eligible participants ≥ 6 years of age had documented CF and chronic infection with Burkholderia spp. 61 participants were male
Interventions	24 weeks of continuous treatment with 75 mg inhaled AZLI (3 times a day) or placebo Followed by a 24‐week extension period of open‐label AZLI treatment for all participants (weeks 24 ‐ 48); and a 4‐week follow‐up period (weeks 48 ‐ 52)
Outcomes	Primary outcome was change in lung function (FEV1) at 24 weeks Secondary outcomes included: number of respiratory exacerbations requiring IV, oral or inhaled antibiotics (or both); number of respiratory hospitalisations; AUCave through week 24 for CF Questionnaire‐Revised (CFQ‐R) Respiratory Symptoms scores; time to respiratory exacerbation requiring IV, oral or inhaled antibiotics (or both); and adverse events
Notes	The study was funded by Gilead Sciences
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not clear how sequences were generated
Allocation concealment (selection bias)	Unclear risk	Not clear how allocation was concealed
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double blinded with identical placebo
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Blinded medical reviewer for subjective outcomes
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Some outcomes reported with significantly reduced participants. Overall, 84% of participants completed the trial and continued onto the extension period)
Selective reporting (reporting bias)	Low risk	No evidence of selective reporting
Other bias	Low risk	No other potential sources of bias were identified

AUC_ave: average area under the curve
 AZLI: aztreonam lysine
 FEV₁: forced expiratory volume in one second
 RCT: randomised controlled trial