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Clinical Trial
. 1998 Dec;102(6 Pt 1):935-42.
doi: 10.1016/s0091-6749(98)70331-8.

Zafirlukast improves asthma symptoms and quality of life in patients with moderate reversible airflow obstruction

R A Nathan  1 , J A Bernstein, L Bielory, C M Bonuccelli, W J Calhoun, S P Galant, L A Hanby, J P Kemp, J W Kylstra, A S Nayak, J P O'Connor, H J Schwartz, D L Southern, S L Spector, P V Williams
Affiliations
Clinical Trial

Zafirlukast improves asthma symptoms and quality of life in patients with moderate reversible airflow obstruction

R A Nathan et al. J Allergy Clin Immunol. 1998 Dec.

Abstract

Background: Previous trials demonstrated the effectiveness of the leukotriene receptor antagonist zafirlukast in patients with mild-to-moderate asthma.

Objectives: We sought to assess the efficacy and safety of zafirlukast and its effect on patients' quality of life (QOL) during a 13-week, double-blind, placebo-controlled, multicenter trial in adults and adolescents with moderate reversible airflow obstruction.

Methods: Patients (age range, 12 to 68 years) with total daytime asthma symptoms scores of 10 or greater over 7 consecutive days (maximum, 21/wk), FEV1 45% or greater but less than or equal to 80% of predicted value (>/=6 hours after beta2 -agonist), and reversible airway disease were randomized to 20 mg zafirlukast twice daily (nZ = 231) or placebo twice daily (nP = 223). Efficacy was assessed from changes in daytime and nocturnal symptoms, beta2 -agonist use, nasal congestion score, and pulmonary function. QOL was evaluated with a disease-specific Asthma Quality of Life Questionnaire. Safety was determined from adverse event information and clinical laboratory test results.

Results: Zafirlukast was significantly (P <.001) more effective than placebo, with reductions from baseline in the daytime asthma symptoms score (-23%), nighttime awakenings with asthma (-19%), and beta2 -agonist use (-24%) and improvements from baseline in morning (+25 L/min) and evening (+18 L/min) peak expiratory flow rates. Compared with placebo, zafirlukast significantly (P </=.018) improved scores for QOL domains (activity limitations, symptoms, emotional function, and exposure to environmental stimuli) and overall QOL, with a significantly greater proportion of zafirlukast-treated patients demonstrating clinically meaningful improvements (>/=0.5-unit change from baseline; P </=.037). The safety profile of zafirlukast was clinically indistinguishable from that of placebo.

Conclusions: Zafirlukast is effective and well tolerated and improves QOL in the long-term treatment of patients with moderate reversible airflow obstruction.

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