title: Zafirlukast improves asthma symptoms and quality of life in patients with moderate reversible airflow obstruction.
abstract: BACKGROUND
  Previous trials demonstrated the effectiveness of the leukotriene receptor antagonist zafirlukast in patients with mild-to-moderate asthma.
  
  
  OBJECTIVE
  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.
authors.affiliation: Asthma & Allergy Associates, Colorado Springs, CO, USA.
authors.forename: R A
authors.initials: RA
authors.lastname: Nathan
authors.forename: J A
authors.initials: JA
authors.lastname: Bernstein
authors.forename: L
authors.initials: L
authors.lastname: Bielory
authors.forename: C M
authors.initials: CM
authors.lastname: Bonuccelli
authors.forename: W J
authors.initials: WJ
authors.lastname: Calhoun
authors.forename: S P
authors.initials: SP
authors.lastname: Galant
authors.forename: L A
authors.initials: LA
authors.lastname: Hanby
authors.forename: J P
authors.initials: JP
authors.lastname: Kemp
authors.forename: J W
authors.initials: JW
authors.lastname: Kylstra
authors.forename: A S
authors.initials: AS
authors.lastname: Nayak
authors.forename: J P
authors.initials: JP
authors.lastname: O'Connor
authors.forename: H J
authors.initials: HJ
authors.lastname: Schwartz
authors.forename: D L
authors.initials: DL
authors.lastname: Southern
authors.forename: S L
authors.initials: SL
authors.lastname: Spector
authors.forename: P V
authors.initials: PV
authors.lastname: Williams
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007211:Indoles; D008173:Lung Diseases, Obstructive / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D048448:Phenylcarbamates; D011788:Quality of Life; D013449:Sulfonamides; D014105:Tosyl Compounds / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D001993:Bronchodilator Agents; D007211:Indoles; D048448:Phenylcarbamates; D013449:Sulfonamides; D014105:Tosyl Compounds; C062735:zafirlukast