Marta San Miguel-Pagola1, Gregory Reychler2, María A Cebrià I Iranzo3, Marta Gómez-Romero4, Fernando Díaz-Gutiérrez5, Beatriz Herrero-Cortina6. 1. Universidad San Jorge, Autovía Mudéjar, km. 299, Villanueva de Gállego, 50830, Zaragoza, Spain; Institut de Recherche Expérimentale et Clinique (IREC), Pneumologie, ORL and Dermatologie, Cliniques Universitaires Saint-Luc, Avenue Hippocrate 10, Woluwe-Saint-Lambert, 1200, Brussels, Belgium. Electronic address: msanmiguelpagola@gmail.com. 2. Institut de Recherche Expérimentale et Clinique (IREC), Pneumologie, ORL and Dermatologie, Cliniques Universitaires Saint-Luc, Avenue Hippocrate 10, Woluwe-Saint-Lambert, 1200, Brussels, Belgium; Service de Pneumologie, Cliniques Universitaires Saint-Luc, Avenue Hippocrate 10, Woluwe-Saint-Lambert, 1200, Brussels, Belgium. Electronic address: gregory.reychler@uclouvain.be. 3. Department of Physiotherapy, Universitat de València, Av. de Blasco Ibáñez, 13, 46010, Valencia, Spain; Physiotherapy, Cardiorespiratory Rehabilitation Service, Hospital Universitari i Politècnic La Fe, Avinguda de Fernando Abril Martorell, 106, 46026, Valencia, Cáceres, Spain. Electronic address: Angeles.Cebria@uv.es. 4. Physiotherapy, Cystic Fibrosis Association, Carrera 8, bajo, 10002, Cáceres, Extremadura, Spain. Electronic address: margomrom@hotmail.com. 5. Physiotherapy, Virgen del Rocío Hospital, Avda. Manuel Siurot, s/n, 41013, Sevilla, Spain. Electronic address: ferdigu@hotmail.com. 6. Universidad San Jorge, Autovía Mudéjar, km. 299, Villanueva de Gállego, 50830, Zaragoza, Spain. Electronic address: beafisiorespi@gmail.com.
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.
RCT Entities:
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.
Authors: Patricia Rocamora-Pérez; María Jesús Benzo-Iglesias; María de Los Ángeles Valverde-Martínez; Amelia Victoria García-Luengo; José Manuel Aguilar-Parra; Rubén Trigueros; Remedios López-Liria Journal: Ther Adv Respir Dis Date: 2022 Jan-Dec Impact factor: 5.158