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Clinical Trial
, 19 (2), 111-9

Efficacy and Safety of Zafirlukast ('Accolate') in the Management of Patients With Mild-To-Moderate Asthma

  • PMID: 11070746
Clinical Trial

Efficacy and Safety of Zafirlukast ('Accolate') in the Management of Patients With Mild-To-Moderate Asthma

C Chukwu et al. West Afr J Med.


The efficacy and safety of the oral leukotriene receptor antagonist Zafirlukast ('Accolate') was assessed as maintenance therapy for black (Nigerian) patients with mild to moderate asthma. A total of eighty-one patients aged 16-70 years were screened and sixty patients were enrolled in a 7-week multicenter open study to receive 20 mg of 'Accolate' twice daily. Those enrolled had FEV1 > or = 60%, reversibility > or = 15% and cumulative daytime asthma symptoms score > or = 10 over seven consecutive days before visit 2 to be considered eligible to receive trial therapy, and the patients were maintained on as required beta 2-agonist therapy. Efficacy was assessed by changes in symptoms, number of times beta 2-agonist was used and results of pulmonary function tests. Safety was assessed by adverse event experiences, results of laboratory tests and physical examination. At the endpoint, patients reported a statistically significant increase in lung function and a significant reduction in episodes of asthma symptoms either in the morning, day or night. The mean beta 2-agonist use was also statistically reduced over the weeks as treatment progressed while the cumulative daytime total asthma score showed a sharp decline following drug use. Change in symptoms, beta 2-agonist use and pulmonary function occurred within one week of Zafirlukast treatment and continued throughout the trial. Zafirlukast was well tolerated. Headaches and pneumonia were the only side effects in three patients and these were not considered to be related to trial therapy. No clinically significant changes were observed in laboratory test results, or on physical examination. We conclude that Zafirlukast ('Accolate') 20 mg b.d. is an effective and well tolerated medication for maintenance therapy in black (Nigerian) patients with mild-to-moderate asthma.

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