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A randomized, open labeled, comparative study to assess the efficacy and safety of controller medications as add on to inhaled corticosteroid and long-acting β2 agonist in the treatment of moderate-to-severe persistent asthma
YA Patel1, P Patel1, H Bavadia2, J Dave2, CB Tripathi1
1 Department of Pharmacology, Government Medical College, Bhavnagar-364001, Gujarat, India
2 Department of Tuberculosis and Respiratory diseases, Sir Takhtsinghji hospital and Government Medical College, Bhavnagar-364001, Gujarat, India
Correspondence Address:
C B Tripathi
Department of Pharmacology, Government Medical College, Bhavnagar-364001, Gujarat
India
Background : The goal of asthma therapy is to achieve clinical control and near normal lung functions. Many patients with persistent asthma fail to achieve this goal with a single controller medication add on to a inhaled corticosteroid. We have checked whether another controller medication add on to inhaled corticosteroid and long-acting β2 agonist helps in achieving the asthma goal or not. Objectives : To identify the effect of controller medication add on to inhaled corticosteroid and the long-acting β2 agonist on the clinical symptom, lung function, and compliance in patients with asthma. Materials and Methods : We conducted a randomized, open-labeled, comparative trial in 50 participants with moderate-to-severe persistent asthma. The study duration was of 10 weeks. During the first two weeks of the run-in period all the participants received a dry powder inhaler drug delivery of budesonide (400 mcg/day) and formoterol (12 mcg/day) combination. At the end of the run-in period the participants were randomly allocated into three groups: group A (n = 16) received oral montelukast (10 mg/day); group B (n = 17) received oral doxophylline (400 mg/day), and group C (n = 17) received inhaled budesonide (400 mcg) as add on to the above-mentioned drugs of the run-in period. The primary outcome was improvement in forced expiratory volume at 1 second (FEV 1 ). Results : All the participants of the three groups had significant improvement in FEV 1 (P < 0.001) and asthma symptoms at the end of 10 weeks. The mean increase in FEV 1 (% of predicted) from the baseline, in groups A, B, and C was: 24.6; 21.33, and 19.86%, respectively. Conclusions : All add on controller medications helped, with a significant improvement of lung functions and asthma symptoms.
How to cite this article:
Patel Y A, Patel P, Bavadia H, Dave J, Tripathi C B. A randomized, open labeled, comparative study to assess the efficacy and safety of controller medications as add on to inhaled corticosteroid and long-acting β2 agonist in the treatment of moderate-to-severe persistent asthma.J Postgrad Med 2010;56:270-274
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How to cite this URL:
Patel Y A, Patel P, Bavadia H, Dave J, Tripathi C B. A randomized, open labeled, comparative study to assess the efficacy and safety of controller medications as add on to inhaled corticosteroid and long-acting β2 agonist in the treatment of moderate-to-severe persistent asthma. J Postgrad Med [serial online] 2010 [cited 2023 Mar 28 ];56:270-274
Available from: https://www.jpgmonline.com/article.asp?issn=0022-3859;year=2010;volume=56;issue=4;spage=270;epage=274;aulast=Patel;type=0 |
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