TY - JOUR
T1 - Impact of Hypertonic Saline Solutions on Sputum Expectoration and Their Safety Profile in Patients with Bronchiectasis
T2 - A Randomized Crossover Trial
AU - Herrero-Cortina, Beatriz
AU - Alcaraz, Victoria
AU - Vilaró, Jordi
AU - Torres, Antoni
AU - Polverino, Eva
N1 - Funding Information:
This project was sponsored by Praxis Pharmaceuticals and Chiesi Farmaceutici, providing the study drug (hyaluronate acid + hypertonic saline solutions). Funding sources had no involvement in the study concept or design; in the collection, analysis, or interpretation of data; in the writing of the report or in the decision to submit the article for publication.
Publisher Copyright:
© Beatriz Herrero-Cortina, et al., 2018. Published by Mary Ann Liebert, Inc.
PY - 2018/10
Y1 - 2018/10
N2 - Background: The role of hyaluronic acid plus hypertonic saline (HA+HS) as a mucoactive treatment in patients with bronchiectasis is still unknown. This study evaluated whether HA+HS solution enhances similar sputum quantity with better safety profile than HS alone in patients with bronchiectasis. Methods: In this double-blind randomized crossover trial, three solutions (7% HS; 0.1% HA +7%HS; and 0.9% isotonic saline, IS) were compared in outpatients with bronchiectasis and chronic sputum expectoration. Participants inhaled each solution across four consecutive sessions. All sessions, except on session 3, also included 30 minutes of airway clearance technique. A 7-day washout period was applied. Sputum weight was collected during the sessions (primary outcome) as well as during a 24-hour follow-up. The Leicester Cough Questionnaire (LCQ) and lung function were measured before/after each treatment arm. Safety was assessed by the monitoring of adverse events (AEs). Results: Twenty-eight patients with bronchiectasis (mean age of 64.0 (17.9) and FEV 1 % 60.9 (24.6) of predicted) were recruited. HS and HA+HS promoted similar expectoration during sessions, both being greater than IS [median difference HS vs. IS 3.7 g (95% CI 0.5-6.9); HA+HS vs. IS 3.2 g (95%CI 0.5-5.9)]. Sputum expectorated exclusively during the ACT period was similar across all treatment arms [HS vs. IS -0.3 g (95% CI -1.7 to 0.9); HA+HS vs. IS 0.0 g (95% CI -1.3 to 1.4); HS vs. HA+HS 0.0 g (95% CI -1.2 to 0.4)]. Sputum collected over the 24-hour follow-up tended to be lower for HS and HA+HS compared with IS [HS vs. IS -1.7 g (95% CI -4.2 to 0.0); HA+HS vs. IS -1.1 g (95%CI -3.6 to 0.7)]. No differences in LCQ or lung function were observed. Most severe AEs were reported using HS. Conclusion: HS and HA+HS were more effective on sputum expectoration than IS in patients with bronchiectasis, reporting HA+HS better safety profile than HS.
AB - Background: The role of hyaluronic acid plus hypertonic saline (HA+HS) as a mucoactive treatment in patients with bronchiectasis is still unknown. This study evaluated whether HA+HS solution enhances similar sputum quantity with better safety profile than HS alone in patients with bronchiectasis. Methods: In this double-blind randomized crossover trial, three solutions (7% HS; 0.1% HA +7%HS; and 0.9% isotonic saline, IS) were compared in outpatients with bronchiectasis and chronic sputum expectoration. Participants inhaled each solution across four consecutive sessions. All sessions, except on session 3, also included 30 minutes of airway clearance technique. A 7-day washout period was applied. Sputum weight was collected during the sessions (primary outcome) as well as during a 24-hour follow-up. The Leicester Cough Questionnaire (LCQ) and lung function were measured before/after each treatment arm. Safety was assessed by the monitoring of adverse events (AEs). Results: Twenty-eight patients with bronchiectasis (mean age of 64.0 (17.9) and FEV 1 % 60.9 (24.6) of predicted) were recruited. HS and HA+HS promoted similar expectoration during sessions, both being greater than IS [median difference HS vs. IS 3.7 g (95% CI 0.5-6.9); HA+HS vs. IS 3.2 g (95%CI 0.5-5.9)]. Sputum expectorated exclusively during the ACT period was similar across all treatment arms [HS vs. IS -0.3 g (95% CI -1.7 to 0.9); HA+HS vs. IS 0.0 g (95% CI -1.3 to 1.4); HS vs. HA+HS 0.0 g (95% CI -1.2 to 0.4)]. Sputum collected over the 24-hour follow-up tended to be lower for HS and HA+HS compared with IS [HS vs. IS -1.7 g (95% CI -4.2 to 0.0); HA+HS vs. IS -1.1 g (95%CI -3.6 to 0.7)]. No differences in LCQ or lung function were observed. Most severe AEs were reported using HS. Conclusion: HS and HA+HS were more effective on sputum expectoration than IS in patients with bronchiectasis, reporting HA+HS better safety profile than HS.
KW - airway clearance techniques
KW - bronchiectasis
KW - hypertonic solutions
KW - mucoactive treatment
KW - sputum expectoration
UR - http://www.scopus.com/inward/record.url?scp=85054056815&partnerID=8YFLogxK
U2 - 10.1089/jamp.2017.1443
DO - 10.1089/jamp.2017.1443
M3 - Article
C2 - 29878856
AN - SCOPUS:85054056815
SN - 1941-2711
VL - 31
SP - 281
EP - 289
JO - Journal of Aerosol Medicine and Pulmonary Drug Delivery
JF - Journal of Aerosol Medicine and Pulmonary Drug Delivery
IS - 5
ER -