An open study to evaluate the safety and efficacy of zafirlukast ("Accolate") in patients with mild to moderate asthma in Ibadan, Nigeria.

An open study to evaluate the safety and efficacy of Zafirlukast (oral leukotriene-receptor antagonist) in patients with mild to moderate asthma was conducted at the out-patient department of the University College Hospital (UCH), Ibadan. A total of 30 patients aged 16-70 years were screened into the trial but 20 patients that fulfilled the inclusion and exclusion criteria were enrolled in a 7-week open study to receive 20mg b.i.d. of "Accolate". Efficacy of treatment was assessed by changes in symptoms, beta-agonist use and pulmonary function tests (PEFR and FEV1). Safety was assessed by adverse experiences, laboratory test results, results of physical examination and chest-x-ray (when necessary). Zafirlukast (Accolate) significantly decreased daytime asthma symptoms scores (28.8%), night-time awakenings (80.76%), morning with asthma (36.4%) and beta-agonist use (31.3%) and significantly increased the mean PEFR values (11.3%); FEV, (17.4%) at end point from their baseline values. Changes in symptoms, beta-agonist use, and pulmonary function occurred within the first week of zafirlukast treatment and continued throughout the trial. Zafirlukast was well tolerated. Headache was reported in two patients. No significant changes were observed in laboratory test results, findings on physical examination. I concluded that zafirlukast produces early and sustained effects in the treatment of mild-to-moderate asthma.

Citation

O M Ige, B O Onadeko. An open study to evaluate the safety and efficacy of zafirlukast ("Accolate") in patients with mild to moderate asthma in Ibadan, Nigeria. West African journal of medicine. 2001 Oct-Dec;20(4):220-6

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PMID: 11885876

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