MetaNeb Versus Usual Care During Exacerbations of Cystic Fibrosis: An RCT.

Abstract

Background and objective: During exacerbations, when symptom and treatment burden are increased, individuals with cystic fibrosis (CF) are likely to prefer airway clearance techniques (ACTs) that require minimal effort. Therefore, in adults with CF who were hospitalised with an exacerbation, we sought to compare the effect of the MetaNeb with usual ACTs on respiratory function and expectorated sputum.

Methods: This was a non-blinded randomised controlled trial where adults hospitalised with a CF exacerbation were allocated to an experimental intervention (EIx; MetaNeb) or a control intervention (CIx; their usual ACT). Both groups underwent twice-daily supervised airway clearance sessions, over an intervention period that ranged from 5 to 7 days during their hospitalisation. The primary outcome was ventilation inhomogeneity measured via lung clearance index (LCI) using the multiple breath washout technique. Secondary outcomes included adverse events, respiratory mechanics, forced expiratory volumes, sputum inflammatory markers, wellness, expectorated sputum, symptoms, participant satisfaction, and huff and cough counts.

Results: Thirty participants were randomised (EIx group n = 14; CIx group n = 16). On completion of the intervention period, there was a greater improvement in LCI following the EIx than CIx (mean difference -0.84 units [-1.66 to -0.02], as well as some measures of respiratory mechanics. There were no between-group differences for the other secondary outcomes.

Conclusion: In adults with CF who were hospitalised with an exacerbation, twice daily MetaNeb produced greater improvements in ventilation inhomogeneity compared to twice daily usual ACTs. There were no between-group differences shown for the other outcomes, including respiratory symptoms.

Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12619001681145).