Indian Journal of Health Sciences and Biomedical Research KLEU (Jan 2017)
Clinical effectiveness of anticholinergic tiotropium bromide as an add-on therapy in patients with severe bronchial asthma: A randomized controlled trial
Abstract
Background and Objectives: Severe asthma seen in substantial proportion of patients has been a poorly controlled disease, with recurring symptoms and exacerbations despite the use of inhaled glucocorticoids (ICS), long-acting beta-agonists (LABAs-2), leukotriene receptor antagonist (LTRA), and theophyllines. A potential alternative approach is addition of a second bronchodilator with an alternative mode of action, the anticholinergic tiotropium bromide. Hence, the present study was undertaken to evaluate clinical effectiveness of tiotropium bromide 18 mcg as add-on therapy in severe asthma patients. Methodology: A single-blinded randomized study was carried in patients with severe asthma. The patients were randomized into two groups. The study group received an addition of 18 mcg of tiotropium while both groups were continued on LABA and high dose ICS combination, theophyllines, and LTRA. Improvement in lung function (forced expiratory volume in 1 s [FEV1], forced vital capacity [FVC], and peak expiratory flow rate [PEFR]), clinical symptoms, and quality of life were assessed by mini asthma quality of life questionnaire (mini-AQLQ) at 4, 8, and 12 weeks. Results: Seventy patients were included in the study, of which 63 completed the study period. Baseline characteristics were well matched between the groups. At the end of 12 weeks, the tiotropium group showed a mean improvement in FEV1 and FVC of 450 ml and 560 ml, respectively, as compared to the control group (P < 0.0001). PEFR showed mean difference of 16.8 L/min in the study group at the end of 12 weeks as compared to the control group and it was statistically significant (P < 0.0001). Quality of life as assessed by mini-AQLQ was statistically significant in study group as compared to control group (3.42 vs. 3.07; P < 0.0001). In study group, about 21 patients (65.62%) had no exacerbations compared to eight patients (25.8%) in the control group (P = 0.045). Conclusions: The addition of once-daily tiotropium to severe asthma treatment regimen including high-dose ICS plus LABA, theophyllines, and LTRA significantly improves lung functions and quality of life over 12 weeks of therapy.
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