Effect of montelukast on patients with mild persistant asthma

ABSTRACT

To determine the clinical effects of oral montelukast sodium [a leukotriene receptor antagonists] in asthmatic patients aged 15 years and above. This was a 2 month [60 days] study carried out in the Department of Pharmacology and therapeutics, Basic Medical Sciences Institute with collaboration of Chest Medicine, JPMc, Karachi. Patients> 15 years and above suffering from persistant asthma [prebronchodilator FEVI = 60% of the predicted value] and insufficiently controlled on inhaled corticosteroids were included in the study. Total of 100 patients completed the study. The study comprised of two arms of 50 patients each. Group A was the control group on the placebo group receiving inhaled corticosteroids and a placebo drug. Group B was the active group or the drug group receiving inhaled steroids as well as 10 mg montelukast at bed time. Asthma control was assessed by spirometery [name model No.] at the onset i.e. start of the study and then after 60 days i.e. end of the study as per the specifications and guide lines laid down by the global initiative for asthma. Along with this the patients were evaluated weekly in which PEER was measured using a peak expiratorv flow meter. Similarly the ptient was asked to maintain a daily diary in which day time asthma symptoms were recorded along with nocturnal awakenings. use of beta2 agonists use, asthma exacerbations and asthma free days and use of health related resources for worsening asthma symptoms. Montelukast improved airway obstruction FEVJ-PEFR and patients reported end points i.e. day time asthma symptoms, nocturnal awakenings [P<0.001 compared with placebo]. The comparison of difference in mean value of PEFR, FEVI and nocturnal awakenings among two groups from baseline to 811 week was compared by students t-test [test for two independent groups for mean]. 95% confidence interval of the difference of mean was also calculated. Montelukast, compared with placebo significantly improved asthma control during a 8 week treatment period