The Journal of Allergy and Clinical Immunology
Volume 102, Issue 6 , Pages 935-942 , December 1998

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

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    Least-squares means (repeated-measures analysis) for daytime asthma symptoms score during 13 weeks of double-blind treatment with zafirlukast or placebo. A significant treatment difference, favoring z

    Least-squares means (repeated-measures analysis) for daytime asthma symptoms score during 13 weeks of double-blind treatment with zafirlukast or placebo. A significant treatment difference, favoring zafirlukast, was noted across the treatment period (P < .001).

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    Least-squares means (repeated-measures analysis) for nighttime awakenings with asthma during 13 weeks of double-blind treatment with zafirlukast or placebo. A significant treatment difference, favorin

    Least-squares means (repeated-measures analysis) for nighttime awakenings with asthma during 13 weeks of double-blind treatment with zafirlukast or placebo. A significant treatment difference, favoring zafirlukast, was noted across the treatment period (P < .001).

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    Least-squares means (repeated-measures analysis) for nasal congestion score during 13 weeks of double-blind treatment with zafirlukast or placebo. A significant treatment difference, favoring zafirluk

    Least-squares means (repeated-measures analysis) for nasal congestion score during 13 weeks of double-blind treatment with zafirlukast or placebo. A significant treatment difference, favoring zafirlukast, was noted across the treatment period (P < .001).

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    Least-squares means (ANCOVA) for FEV1 (L) during double-blind treatment for patients in zafirlukast or placebo groups who had a baseline FEV1 less than 65% of predicted. Asterisk (*) denotes significa

    Least-squares means (ANCOVA) for FEV1 (L) during double-blind treatment for patients in zafirlukast or placebo groups who had a baseline FEV1 less than 65% of predicted. Asterisk (*) denotes significant treatment differences, favoring zafirlukast, at all time points, including end point (P < .01).

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    A, Mean change in AQLQ results from baseline to end point for the zafirlukast and placebo groups. At end point, ANCOVA showed that the zafirlukast group (nZ = 196) had significantly greater improvemen

    A, Mean change in AQLQ results from baseline to end point for the zafirlukast and placebo groups. At end point, ANCOVA showed that the zafirlukast group (nZ = 196) had significantly greater improvements from baseline in all 4 QOL domains and the overall QOL assessment score (P ≤ .018) compared with the placebo group (np = 175). Δ indicates the least-squares mean treatment difference at end point (zafirlukast minus placebo). B, Percentage of patients in zafirlukast and placebo groups with a clinically meaningful improvement at end point (≥ 0.5-unit change from baseline) in the 4 QOL domains and overall QOL assessment score (Cochran-Mantel-Haenszel Test). Compared with the placebo group, significantly more patients in the zafirlukast group had clinically meaningful improvements in all QOL domains and the overall QOL assessment score (P ≤ .037). Treatment bars are stratified to show the proportion of patients with clinically meaningful improvements of 0.5 or greater through less than 1.0 units (minimal improvement) and 1.0 units or greater (moderate improvement or better).

 From a Asthma & Allergy Associates, PC, Colorado Springs; b Bernstein Clinical Research Center, Cincinnati; c UMDNJ-New Jersey Medical School, Newark; d Zeneca Pharmaceuticals, Wilmington; e University of Pittsburgh, Pittsburgh; f Asthma & Allergy Research Center, Orange; g Allergy & Asthma Medical Group & Research Center, PC, San Diego; h Asthma & Allergy Research Associates, Inc, Normal; i Thomas Jefferson University, Philadelphia; j University Hospital of Cleveland, Cleveland; k Princeton Allergy & Asthma Associates, PA, Princeton; l Allergy Research Foundation, Inc, Los Angeles; and m Northwest Asthma & Allergy Center, Mount Vernon.

☆☆ *The members of the ACCOLATE Trialists Group are listed in the acknowledgments section.

 Supported by a grant from Zeneca Pharmaceuticals, Wilmington, Del.

★★ Reprints requests: Robert A. Nathan, MD, Asthma & Allergy Associates, PC, 2709 North Tejon, Colorado Springs, CO 80907.

 0091-6749/98 $5.00 + 0 1/1/93582

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The Journal of Allergy and Clinical Immunology
Volume 102, Issue 6 , Pages 935-942 , December 1998