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Impact of hypertonic saline nebulisation combined with oscillatory positive expiratory pressure on sputum expectoration and related symptoms in cystic fibrosis: a randomised crossover trial [with consumer summary]
San Miguel-Pagola M, Reychler G, Cebria IIMA, Gomez-Romero M, Diaz-Gutierrez F, Herrero-Cortina B
Physiotherapy 2020 Jun;107:243-251
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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 24 hours 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 1 second 67 (22)) were recruited. Combined therapy promoted greater sputum expectoration than usual care during the nebulisation period (median difference 1.8 ml (95% confidence interval (CI) 0.2 to 6.2)). Both treatments led to similar expectoration during autogenic drainage and for 24 hours post intervention. Combined therapy led to a greater improvement in the sputum symptoms domain (6.7 points (95% CI 3.3 to 13.3) and total CASA-Q score (2.4 points (95% CI 0.1 to 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.

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