Accepted for/Published in: Interactive Journal of Medical Research
Date Submitted: Jan 17, 2020
Date Accepted: Feb 29, 2020
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Health related observational study on Home Nebulization with Long-acting bronchodilators in Difficult-to-control asthma: Post-hoc analyses
ABSTRACT
Background:
Bronchial asthma remains a clinical enigma with poorly controlled symptoms or exacerbations despite optimal use of ICS/LABA. Home nebulization offers customized or individualized therapy to Severe asthma patients with phenotypic characteristics, and/or preferences for a simplified inhalational device for delivery of long-acting bronchodilators especially for cases with frequent exacerbations often requiring use of rescue medications in Uncontrolled or Difficult to treat asthma
Objective:
To assess the clinical impact and outcome associated with Long-acting bronchodilators delivered by Home Nebulization in Uncontrolled or Difficult-to-treat asthma
Methods:
an observational, concurrent study on Home Nebulization was conducted (n=60) as per ICH-GCP principles at two centres during November ’18 with an institutional ethics committee approval. Statistical analyses for patients receiving long-acting beta2-agonists &/or anticholinergics was carried out by QuickCalcs GraphPad Prism ver. 7 software
Results:
Per protocol analyses (53/60) for consecutive cases receiving Home nebulization with long-acting bronchodilators was conducted. Baseline demographics included Male/Female (30/23); mean Age 60.3y11.8 ; Wt 64kg 16.8 ; FEV1 (4316%); GINA Asthma control score (3.00.8); Uncontrolled symptoms 53 (100%); Prior Exacerbation 37 (69.8%); Serum eosinophil (43%); FeNO (12.16 ppb); Form/Bud (53,100%), Glycopyrronium (40,75.5%). per protocol group (n= 53) showed significant improvement in prebronchodilator FEV1, GINA Asthma control scores of 23.729.8% (0.460.58 L) and 2.10.8 respectively (P<.0001). Post-hoc analyses for patients (n=40) receiving Glycopyrronium 25 /Form 20/BUD 500 mcg nebulization admixture with prebronchodilator FEV1 (38%15%), GINA Asthma control score (3.00.8), Reversibility (126%), peripheral eosinophil (4%3), FeNO (12%5.7 ppb) showed significant improvement (P<.0001) in prebronchodilator FEV1 by 27.726.2% (0.540.51 L) at 8 wks compared to baseline. Similarly subjects (n=13) receiving Formoterol/Budesonide (20/500 mcg) nebulization with baseline FEV1 (5512%), GINA Asthma control score (3.01.2), Reversibility (147%), Serum eosinophil (43%), FeNO (13.36.8ppb) showed significant improvement (p<0.0001) in prebronchodilator FEV1 by 11.213.1% (0.220.25 L) compared to baseline. Ten cases (18.9%) of breathlessness of mild to moderate intensity were reported with no other treatment emergent AEs or SAEs.
Conclusions:
Home nebulization remains a clinically feasible option for symptomatic Difficult to treat asthma cases with frequent use of rescue medication. Use of long acting bronchodilators including Glycopyrronium as add-on therapy offers synergistic response in Difficult to treat or non-eosinophilic asthma that is clinically significant Clinical Trial: Clinical Trial Registry of India (Registered): CTRI/2018/11/016319
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