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

被引:60
作者
Nathan, RA
Bernstein, JA
Bielory, L
Bonuccelli, CM
Calhoun, WJ
Galant, SP
Hanby, LA
Kemp, JP
Kylstra, JW
Nayak, AS
O'Connor, JP
Schwartz, HJ
Southern, DL
Spector, SL
Williams, PV
机构
[1] Asthma & Allergy Associates PC, Colorado Springs, CO 80907 USA
[2] Bernstein Clin Res Ctr, Cincinnati, OH USA
[3] Univ Med & Dent New Jersey, New Jersey Med Sch, Newark, NJ 07103 USA
[4] Zeneca Pharmaceut, Wilmington, DE USA
[5] Univ Pittsburgh, Pittsburgh, PA USA
[6] Asthma & Allergy Res Ctr, Orange, CA USA
[7] Allergy & Asthma Med Grp & Res Ctr PC, San Diego, CA USA
[8] Asthma & Allergy Res Associates PA, Normal, IL USA
[9] Thomas Jefferson Univ, Philadelphia, PA 19107 USA
[10] Univ Hosp Cleveland, Cleveland, OH 44106 USA
[11] Princeton Allergy & Asthma Associates PA, Princeton, NJ USA
[12] Allergy Res Fdn Inc, Los Angeles, CA USA
[13] NW Asthma & Allergy Ctr, Mt Vernon, IA USA
关键词
D O I
10.1016/S0091-6749(98)70331-8
中图分类号
R392 [医学免疫学];
学科分类号
100102 ;
摘要
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 (greater than or equal to 6 hours after beta(2)-agonist), and reversible airway disease were randomized to 20 mg zafirlukast twice daily (n(Z) = 231) or placebo twice daily (n(P) = 223). Efficacy was assessed from changes in daytime and nocturnal symptoms, beta(2)-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 beta(2)-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 less than or equal to .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 (greater than or equal to 0.5-unit change from baseline; P less than or equal to .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.
引用
收藏
页码:935 / 942
页数:8
相关论文
共 22 条
[2]   THE APPLICATION OF REML IN CLINICAL-TRIALS [J].
BROWN, HK ;
KEMPTON, RA .
STATISTICS IN MEDICINE, 1994, 13 (16) :1601-1617
[3]   THE LEUKOTRIENE D-4-RECEPTOR ANTAGONIST, ICI-204,219, RELIEVES SYMPTOMS OF ACUTE SEASONAL ALLERGIC RHINITIS [J].
DONNELLY, AL ;
GLASS, M ;
MINKWITZ, MC ;
CASALE, TB .
AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE, 1995, 151 (06) :1734-1739
[4]   Zafirlukast for symptomatic mild-to-moderate asthma: A 13-week multicenter study [J].
Fish, JE ;
Kemp, JP ;
Lockey, RF ;
Glass, M ;
Hanby, LA ;
Bonuccelli, CM ;
Bronsky, E ;
Condemi, J ;
Goldstein, S ;
Norton, J ;
Rosenthal, R ;
Silvers, W ;
Tinkelman, D ;
Weisberg, S ;
Winder, J .
CLINICAL THERAPEUTICS, 1997, 19 (04) :675-690
[5]   Interpreting treatment effects in randomised trials [J].
Guyatt, GH ;
Juniper, EF ;
Walter, SD ;
Griffith, LE ;
Goldstein, RS .
BRITISH MEDICAL JOURNAL, 1998, 316 (7132) :690-693
[6]  
HENDERSON WR, 1994, ANN ALLERGY, V72, P272
[7]   Effect of treatment with zileuton, a 5-lipoxygenase inhibitor, in patients with asthma - A randomized controlled trial [J].
Israel, E ;
Cohn, J ;
Dube, L ;
Drazen, JM .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 1996, 275 (12) :931-936
[8]   Quality of life questionnaires: Does statistically significant = clinically important? [J].
Juniper, EF .
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, 1998, 102 (01) :16-17
[9]   QUALITY-OF-LIFE IN ASTHMA CLINICAL-TRIALS - COMPARISON OF SALMETEROL AND SALBUTAMOL [J].
JUNIPER, EF ;
JOHNSTON, PR ;
BORKHOFF, CM ;
GUYATT, GH ;
BOULET, LP ;
HAUKIOJA, A .
AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE, 1995, 151 (01) :66-70
[10]   DETERMINING A MINIMAL IMPORTANT CHANGE IN A DISEASE-SPECIFIC QUALITY-OF-LIFE QUESTIONNAIRE [J].
JUNIPER, EF ;
GUYATT, GH ;
WILLAN, A ;
GRIFFITH, LE .
JOURNAL OF CLINICAL EPIDEMIOLOGY, 1994, 47 (01) :81-87