@Article{info:doi/10.2196/17863,
author="Talwar, Deepak
and Bendre, Salil",
title="Health-Related Effects of Home Nebulization With Glycopyrronium on Difficult-to-Treat Asthma: Post-Hoc Analyses of an Observational Study",
journal="Interact J Med Res",
year="2020",
month="Apr",
day="29",
volume="9",
number="2",
pages="e17863",
keywords="difficult-to-treat asthma; exacerbation; glycopyrronium; home nebulization; uncontrolled asthma; vibrating mesh nebulizer",
abstract="Background: Bronchial asthma remains a clinical enigma with poorly controlled symptoms or exacerbations despite regular use of inhaled corticosteroids. Home nebulization offers a simplified solution for the delivery of rescue and maintenance bronchodilators, which is especially true for patients with frequent exacerbations during management of uncontrolled or difficult-to-treat asthma. Objective: We aimed to assess the clinical impact and outcomes associated with home nebulization---delivered long-acting bronchodilators for uncontrolled or difficult-to-treat asthma. Methods: This observational, concurrent study was conducted with 60 patients at 2 centers during November 2018. Statistical analyses for prebronchodilator forced expiratory volume in one second (FEV1) and Global Initiative for Asthma (GINA) asthma control score in patients on long-acting bronchodilators and corticosteroids were conducted, with two-tailed P values <.05 considered statistically significant. Results: Per protocol analyses (53/60) for consecutive cases receiving home nebulization with long-acting bronchodilators and corticosteroids were conducted. The baseline demographics included a male-to-female ratio of 30:23 and mean values of the following: age, 60.3 years (SD 11.8 years); weight, 64 kg (SD 16.8 kg); FEV1, 43{\%} (SD 16{\%}); GINA asthma control score, 3.0 points (SD 0.8 points); serum eosinophil level, 4{\%} (SD 3{\%}); fractional exhaled nitric oxide (FeNO), 12.1 ppb (SD 6 ppb). Of the patients, 100{\%} (53/53) had uncontrolled symptoms, 69.8{\%} (37/53) had prior exacerbations, 100{\%} (53/53) used formoterol/budesonide, and 75.5{\%} (40/53) used glycopyrronium. The per protocol group (n=53) had significantly improved mean prebronchodilator FEV1 (23.7{\%}, SD 29.8{\%}; 0.46 L, SD 0.58 L; P<.001) and GINA asthma control score (2.1 points, SD 0.8 points, P<.001). At baseline, patients (n=40) receiving glycopyrronium/formoterol/budesonide (25/20/500 mcg) nebulization admixture had the following mean values: prebronchodilator FEV1, 38{\%} (SD 15{\%}); GINA asthma control score, 3.0 points (SD 0.8 points); reversibility, 12{\%} (SD 6{\%}); peripheral eosinophil level, 4{\%} (SD 3{\%}); FeNO, 12 ppb (SD 5.7 ppb). In the post hoc analyses, these patients had significantly improved mean prebronchodilator FEV1 of 27.7{\%} (SD 26.2{\%}; 0.54 L, SD 0.51 L; P<.001) at 8 weeks compared with baseline. At baseline, patients (n=13) receiving formoterol/budesonide (20/500 mcg) nebulization had the following mean values: FEV1, 55{\%} (SD 12{\%}); GINA asthma control score, 3.0 points (SD 1.2 points); reversibility, 14{\%} (SD 7{\%}); serum eosinophil level, 4{\%} (SD 3{\%}); FeNO, 13.3 ppb (SD 6.8 ppb). In the post hoc analyses, these patients showed a significant improvement in prebronchodilator FEV1 of 11.2{\%} (SD 13.1{\%}; 0.22 L, SD 0.25 L; P<.001) from baseline. Breathlessness of mild to moderate intensity was reported by 10 cases (10/53, 18.9{\%}), with no other treatment-emergent adverse events or serious adverse events. Conclusions: Home nebulization remains a viable option for symptomatic difficult-to-treat asthma cases with frequent use of rescue medications. Glycopyrronium as add-on therapy offers a synergistic response in patients on corticosteroids with difficult-to-treat asthma. Trial Registration: Clinical Trial Registry of India CTRI/2018/11/016319; https://tinyurl.com/y78cctm3 ",
issn="1929-073X",
doi="10.2196/17863",
url="http://www.i-jmr.org/2020/2/e17863/",
url="https://doi.org/10.2196/17863",
url="http://www.ncbi.nlm.nih.gov/pubmed/32347812"
}