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Zafirlukast improves asthma control in patients receiving high-dose inhaled corticosteroids.
Am J Respir Crit Care Med. 2000 Aug; 162(2 Pt 1):578-85.AJ

Abstract

Not all asthma can be adequately controlled, despite the use of high-dose inhaled corticosteroids. Because cysteinyl-leukotrienes (Cys-LT) have been implicated in the pathogenesis of asthma, we hypothesized that the leukotriene receptor antagonist zafirlukast, in combination with high-doses of inhaled corticosteroids, might be efficacious in severe asthma. In a double-blind, parallel group study, 368 chronic adult asthmatic patients treated with inhaled corticosteroids (1,000 to 4,000 microgram/d), who had a predefined level of asthma symptoms during the run in period of the study, were randomly assigned to receive additional treatment with a high dose of zafirlukast (80 mg twice daily) (n = 180) or placebo (n = 188) for 6 wk. Compared with placebo, zafirlukast produced a significant improvement over baseline in the primary study endpoint of mean morning peak expiratory flow rate (PEFR) (18.7 L/min versus 1.5 L/min, p < 0.001), as well as in evening PEFR (p < 0.01), FEV(1) (p < 0.05), daytime symptom score (p < 0.001), and beta(2)-agonist use (p < 0.001). Furthermore, zafirlukast significantly reduced the risk of an exacerbation of asthma (odds ratio [OR]: 0.61; 95% confidence interval [CI]: 0.38 to 0.99) and the risk of patients requiring a further increase in asthma controller therapy (OR: 0.4; 95% CI: 0.2 to 0.8). In conclusion, in patients taking high-dose inhaled corticosteroids, zafirlukast improves pulmonary function and asthma symptoms, and reduces the risk of an asthma exacerbation, suggesting that the contribution of leukotrienes to asthma symptoms and exacerbations is not adequately controlled by high-dose inhaled corticosteroids.

Authors+Show Affiliations

Department of Pneumology, University Medical Clinic Freiburg, Germany; and AstraZeneca Pharmaceuticals, Macclesfield, United Kingdom. virchow@pnm1.ukl.unifreiburg.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

10934090

Citation

Virchow, J C., et al. "Zafirlukast Improves Asthma Control in Patients Receiving High-dose Inhaled Corticosteroids." American Journal of Respiratory and Critical Care Medicine, vol. 162, no. 2 Pt 1, 2000, pp. 578-85.
Virchow JC, Prasse A, Naya I, et al. Zafirlukast improves asthma control in patients receiving high-dose inhaled corticosteroids. Am J Respir Crit Care Med. 2000;162(2 Pt 1):578-85.
Virchow, J. C., Prasse, A., Naya, I., Summerton, L., & Harris, A. (2000). Zafirlukast improves asthma control in patients receiving high-dose inhaled corticosteroids. American Journal of Respiratory and Critical Care Medicine, 162(2 Pt 1), 578-85.
Virchow JC, et al. Zafirlukast Improves Asthma Control in Patients Receiving High-dose Inhaled Corticosteroids. Am J Respir Crit Care Med. 2000;162(2 Pt 1):578-85. PubMed PMID: 10934090.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Zafirlukast improves asthma control in patients receiving high-dose inhaled corticosteroids. AU - Virchow,J C,Jr AU - Prasse,A, AU - Naya,I, AU - Summerton,L, AU - Harris,A, PY - 2000/8/10/pubmed PY - 2000/9/23/medline PY - 2000/8/10/entrez SP - 578 EP - 85 JF - American journal of respiratory and critical care medicine JO - Am J Respir Crit Care Med VL - 162 IS - 2 Pt 1 N2 - Not all asthma can be adequately controlled, despite the use of high-dose inhaled corticosteroids. Because cysteinyl-leukotrienes (Cys-LT) have been implicated in the pathogenesis of asthma, we hypothesized that the leukotriene receptor antagonist zafirlukast, in combination with high-doses of inhaled corticosteroids, might be efficacious in severe asthma. In a double-blind, parallel group study, 368 chronic adult asthmatic patients treated with inhaled corticosteroids (1,000 to 4,000 microgram/d), who had a predefined level of asthma symptoms during the run in period of the study, were randomly assigned to receive additional treatment with a high dose of zafirlukast (80 mg twice daily) (n = 180) or placebo (n = 188) for 6 wk. Compared with placebo, zafirlukast produced a significant improvement over baseline in the primary study endpoint of mean morning peak expiratory flow rate (PEFR) (18.7 L/min versus 1.5 L/min, p < 0.001), as well as in evening PEFR (p < 0.01), FEV(1) (p < 0.05), daytime symptom score (p < 0.001), and beta(2)-agonist use (p < 0.001). Furthermore, zafirlukast significantly reduced the risk of an exacerbation of asthma (odds ratio [OR]: 0.61; 95% confidence interval [CI]: 0.38 to 0.99) and the risk of patients requiring a further increase in asthma controller therapy (OR: 0.4; 95% CI: 0.2 to 0.8). In conclusion, in patients taking high-dose inhaled corticosteroids, zafirlukast improves pulmonary function and asthma symptoms, and reduces the risk of an asthma exacerbation, suggesting that the contribution of leukotrienes to asthma symptoms and exacerbations is not adequately controlled by high-dose inhaled corticosteroids. SN - 1073-449X UR - https://www.unboundmedicine.com/medline/citation/10934090/Zafirlukast_improves_asthma_control_in_patients_receiving_high_dose_inhaled_corticosteroids_ L2 - https://www.atsjournals.org/doi/10.1164/ajrccm.162.2.9905041?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -