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Year : 2010  |  Volume : 56  |  Issue : 4  |  Page : 270-274

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

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
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Source of Support: Gift samples received from Ranbaxy Laboratories and German Remedies, Conflict of Interest: None

DOI: 10.4103/0022-3859.70937

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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.


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Online since 12th February '04
2004 - Journal of Postgraduate Medicine
Official Publication of the Staff Society of the Seth GS Medical College and KEM Hospital, Mumbai, India
Published by Wolters Kluwer - Medknow