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

Robert A. Nathan; Jonathan A. Bernstein; Leonard Bielory; Catherine M. Bonuccelli; William J. Calhoun; Stanley P. Galant; Laura A. Hanby; James P. Kemp; Jelle W. Kylstra; Anjuli S. Nayak; John P. O'Connor; Howard J. Schwartz; D. Loren Southern; Sheldon L. Spector; Paul V. Williams

doi:10.1016/s0091-6749(98)70331-8

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

Robert A. Nathan, Jonathan A. Bernstein, Leonard Bielory, Catherine M. Bonuccelli, William J. Calhoun, Stanley P. Galant, Laura A. Hanby, James P. Kemp, Jelle W. Kylstra, Anjuli S. Nayak, John P. O'Connor, Howard J. Schwartz, D. Loren Southern, Sheldon L. Spector, Paul V. Williams

Research output: Contribution to journal › Article › peer-review

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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 β₂-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, β₂-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 β₂-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.

Original language	English (US)
Pages (from-to)	935-942
Number of pages	8
Journal	Journal of Allergy and Clinical Immunology
Volume	102
Issue number	6 II
DOIs	https://doi.org/10.1016/s0091-6749(98)70331-8
State	Published - 1998
Externally published	Yes

Keywords

Asthma
Leukotriene receptor antagonist
Nasal congestion
Number needed to treat, peripheral blood eosinophils
Pulmonary function
Quality of life
Reversible airflow obstruction
Zafirlukast

ASJC Scopus subject areas

Immunology and Allergy
Immunology

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10.1016/s0091-6749(98)70331-8

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Nathan, R. A., Bernstein, J. A., Bielory, L., Bonuccelli, C. M., Calhoun, W. J., Galant, S. P., Hanby, L. A., Kemp, J. P., Kylstra, J. W., Nayak, A. S., O'Connor, J. P., Schwartz, H. J., Loren Southern, D., Spector, S. L., & Williams, P. V. (1998). Zafirlukast improves asthma symptoms and quality of life in patients with moderate reversible airflow obstruction. Journal of Allergy and Clinical Immunology, 102(6 II), 935-942. https://doi.org/10.1016/s0091-6749(98)70331-8

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, Loren Southern, D, Spector, SL & Williams, PV 1998, 'Zafirlukast improves asthma symptoms and quality of life in patients with moderate reversible airflow obstruction', Journal of Allergy and Clinical Immunology, vol. 102, no. 6 II, pp. 935-942. https://doi.org/10.1016/s0091-6749(98)70331-8

@article{be23b2c3f59c4026ac285c69d817a9ca,

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. 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 β2-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, β2-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 β2-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.",

keywords = "Asthma, Leukotriene receptor antagonist, Nasal congestion, Number needed to treat, peripheral blood eosinophils, Pulmonary function, Quality of life, Reversible airflow obstruction, Zafirlukast",

author = "Nathan, {Robert A.} and Bernstein, {Jonathan A.} and Leonard Bielory and Bonuccelli, {Catherine M.} and Calhoun, {William J.} and Galant, {Stanley P.} and Hanby, {Laura A.} and Kemp, {James P.} and Kylstra, {Jelle W.} and Nayak, {Anjuli S.} and O'Connor, {John P.} and Schwartz, {Howard J.} and {Loren Southern}, D. and Spector, {Sheldon L.} and Williams, {Paul V.}",

note = "Funding Information: Supported by a grant from Zeneca Pharmaceuticals, Wilmington, Del. ",

year = "1998",

doi = "10.1016/s0091-6749(98)70331-8",

language = "English (US)",

volume = "102",

pages = "935--942",

journal = "Journal of Allergy and Clinical Immunology",

issn = "0091-6749",

publisher = "Elsevier Inc.",

number = "6 II",

}

TY - JOUR

T1 - Zafirlukast improves asthma symptoms and quality of life in patients with moderate reversible airflow obstruction

AU - Nathan, Robert A.

AU - Bernstein, Jonathan A.

AU - Bielory, Leonard

AU - Bonuccelli, Catherine M.

AU - Calhoun, William J.

AU - Galant, Stanley P.

AU - Hanby, Laura A.

AU - Kemp, James P.

AU - Kylstra, Jelle W.

AU - Nayak, Anjuli S.

AU - O'Connor, John P.

AU - Schwartz, Howard J.

AU - Loren Southern, D.

AU - Spector, Sheldon L.

AU - Williams, Paul V.

N1 - Funding Information: Supported by a grant from Zeneca Pharmaceuticals, Wilmington, Del.

PY - 1998

Y1 - 1998

N2 - 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 β2-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, β2-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 β2-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.

AB - 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 β2-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, β2-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 β2-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.

KW - Asthma

KW - Leukotriene receptor antagonist

KW - Nasal congestion

KW - Number needed to treat, peripheral blood eosinophils

KW - Pulmonary function

KW - Quality of life

KW - Reversible airflow obstruction

KW - Zafirlukast

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

Abstract

Keywords

ASJC Scopus subject areas

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