Dasenbrook 2015.

Methods	RCT (Phase‐2, double‐blind). Design: parallel. Location: USA. Duration: treatment 28 days, follow up 56 days.
Participants	40 adults and children (≥12 years of age) with CF and sputum culture positive for MRSA at screening, with at least 10,000 CFUs/mL of MRSA.
Interventions	Cohort 1 treatment group: vancomycin inhalation powder (AeroVanc™) 32 mg 2x daily. Cohort 1 control group: placebo inhalation powder 2x daily. Cohort 2: prior to starting enrolment in Cohort 2, a safety evaluation will be carried out by the DMC based on treatment data from the first 20 participants in Cohort 1. Subject to the sponsor's written communication of the DMC's opinion of acceptable safety, the dose for the active arm in Cohort 2 will be escalated to 64 mg 2x daily. Optionally, the active arm for Cohort 2 may also be kept the same (32 mg 2x daily), or reduced to 16 mg 2x daily, depending on the outcome of the DMC's safety evaluation.
Outcomes	Primary outcome change from baseline at Day 29 of the dosing period (start of AeroVanc/placebo administration is considered Day 1 of the dosing period) in the number of MRSA CFUs in sputum culture. Secondary outcomes change from baseline in each pulmonary function test (at days 8, 15 and 29) change from baseline in (CF‐RSD) scores (at days 8, 15 and 29) change from baseline in MRSA sputum density (at days 8 and 15) time from start of dosing to first administration of other antimicrobial medications (oral, IV or inhaled or any combination) due to respiratory symptoms (at day 1 of treatment period through 8‐week post‐treamtent) time from start of dosing to exacerbation of signs or symptoms (Fuchs criteria) (at day 1 of treatment period through 8‐week post‐treamtent) change from baseline in high‐sensitivity CRP and blood neutrophils (at day 29)
Notes	Completed. Full data not yet published.

CF: cystic fibrosis
 CF‐RSD: cystic fibrosis respiratory symptom diary
 CFU: colony forming units
 CRP: C‐reactive protein
 DMC: data monitoring committee
 IV: intravenous
 MRSA: meticillin‐resistant Staphyloccocus aureus
 RCT: randomised controlled trial