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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 beta2 agonist in the treatment of moderate-to-severe persistent asthma.

Author(s): Patel YA, Patel P, Bavadia H, Dave J, Tripathi CB

Affiliation(s): Department of Pharmacology, Government Medical College, Bhavnagar, Gujarat, India.

Publication date & source: 2010-10, J Postgrad Med., 56(4):270-4.

Publication type: Comparative Study; Randomized Controlled Trial

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 beta2 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 beta2 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 (FEV1 ). RESULTS: All the participants of the three groups had significant improvement in FEV1 (P < 0.001) and asthma symptoms at the end of 10 weeks. The mean increase in FEV1 (% 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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