Impact of hypertonic saline nebulisation combined with oscillatory positive expiratory pressure on sputum expectoration and related symptoms in cystic fibrosis: a randomised crossover trial

Abstract

Objective: To evaluate the impact of combining nebulised hyaluronic acid plus hypertonic saline (HA+HS) with oscillatory positive expiratory pressure (oscillatory-PEP) on sputum expectoration and related symptoms in adults with cystic fibrosis (CF).

Design: Randomised crossover trial.

Setting: Seven centres.

Participants: Twenty-two outpatients with CF.

Interventions: Usual care (HA+HS followed by autogenic drainage) and combined therapy (HA+HS with oscillatory-PEP followed by autogenic drainage]. Each treatment was performed for 5 days.

Main outcome measures: Sputum expectoration was measured during the nebulisation period (primary outcome), during autogenic drainage and for 24hours post intervention. The Cough and Sputum Assessment Questionnaire (CASA-Q) and its domains (cough symptoms, cough impact, sputum symptoms and sputum impact), the Leicester Cough Questionnaire (LCQ) and lung function tests were used. Tolerance and patient preference were registered.

Results: Twenty-two participants [mean age 25 (standard deviation 8) years, percentage predicted forced expiratory volume in 1second 67 (22)] were recruited. Combined therapy promoted greater sputum expectoration than usual care during the nebulisation period {median difference 1.8ml [95% confidence interval (CI) 0.2-6.2]}. Both treatments led to similar expectoration during autogenic drainage and for 24hours post intervention. Combined therapy led to a greater improvement in the sputum symptoms domain [6.7 points (95% CI 3.3-13.3] and total CASA-Q score [2.4 points (95% CI 0.1-9.3)] compared with usual care. No differences in LCQ score or lung function were observed. Fewer adverse events were reported using combined therapy, which was selected as the preferred intervention.

Conclusions: Combined nebulisation increased immediate sputum expectoration, improved sputum symptoms and reduced adverse events compared with usual care in patients with CF.

Clinical trial number: NCT02303808.

Keywords: Airway clearance techniques; Cystic fibrosis; Hyaluronic acid; Hypertonic saline; Nebulisation; Sputum.