Tolerability of inhalation of salt particles in COPD patients

Background: Inhaled micronised salt has previously been shown to improve physical performance and quality of life (QoL) in COPD with no adverse events when ad ministered as halo therapy.Aim: To evaluate effect on QoL and adverse events (AE) of salt particle inhalation when inhaled through the Breathox® (B®) device.Methods: Randomized placebo-controlled single blinded four-week trial in COPD patients. Salt particles or placebo were administered through B®. Patients were randomised in three arms: three inhalations twice daily (B3BID), 5 inhalations 4 times daily (B5QID) or 3 placebo inhalations twice daily (P3BID) for 4 weeks. QoL was evaluated with St George Respiratory Questionnaire (SGRQ) at baseline and end of trial. Subgroups were compared by paired-samples T-test.Results: Of 142 patients (B3BID:47/B5QID:46/P3BID:49), 48 % were female, mean age 68 years old, FEV1 42%, 23% active smokers. Median SGRQ at baseline was B3BID:47.8, B5QID: 53,8, P3BID:53,4. Change in SGRQ end of study B3BID:- 4.5/B5QID:-2.8/P3BID:-3.8. Three patients on B3BID, 6 patients on B5QID and 0 patients on P3BID, experienced adverse events (AE). AE’s were local irritation in mouth and throat and cough after inhalation. One patient on B5QID experienced serious adverse event (COPD exacerbation with positive bacterial culture). No patients left the trial due to AE/SAE. There was significant difference in AE between P3BID and B5QID (p=0.01) but no difference between AE’s in P3BID and B3BID or B3BID and B5QID (both p=0.08).Conclusion: QoL improved in B3BID. AE increase with increased dosage of inhaled salt particles. Observed SAE may be incidental. Data indicate that recommendable dose in COPD may be three inhalations twice daily.FootnotesCite this article as: European Respiratory Journal 2020; 56: Suppl. 64, 2987.This abstract was presented at the 2020 ERS International Congress, in session “Respiratory viruses in the "pre COVID-19" era”.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).