Effects of montelukast and beclomethasone on airway function and asthma control


      Background: Maintaining asthma control is a major objective of therapy. Traditionally, the effectiveness of asthma therapy has been judged primarily by its effect on airway function rather than on multiaspect asthma control. Objective: An inhaled corticosteroid and a leukotriene receptor antagonist were compared to determine whether they provided equivalent effects, as judged by days of asthma control. Methods: In a randomized, multicenter, double-blind, placebo-controlled, parallel-group study, asthmatic patients (n = 782) with FEV1 percent predicted values of between 50% and 85% and a weekly average β-agonist use of more than 2 puffs per day were randomized to receive montelukast (10 mg daily), beclomethasone (200 μg twice daily), or placebo treatment for 6 weeks in a double-dummy fashion. We examined the distribution of the primary end point: percentage of days of asthma control. Secondary end points included FEV1, albuterol use, occurrence of an asthma attack, asthma flare-up, rescue corticosteroid use, sustained asthma control, and adverse experiences. Results: The percentage of days of asthma control was almost identical between the montelukast and beclomethasone groups (98% overlap in the distribution). Montelukast was at least equal to beclomethasone, and both were greater than placebo on the basis of frequency of asthma attacks, asthma flare-ups, and rescue corticosteroid use. Beclomethasone had a greater effect than montelukast and both treatments were better than placebo at improving FEV1. Conclusions: Montelukast was as effective as beclomethasone, as judged by indices of clinical control other than FEV1. When evaluating the outcome of montelukast therapy, FEV1 might underestimate clinical effectiveness. (J Allergy Clin Immunol 2002;110:847-54.)



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        • National Asthma Education and Prevention Program
        Expert Panel Report II: guidelines for the diagnosis and management of asthma.
        in: : National Institutes of Health, Bethesda, Md1997: 57-79
        • Kelloway JS
        • Wyatt RA
        • Adlis SA
        Comparison of patients' compliance with prescribed oral and inhaled asthma medications.
        Arch Intern Med. 1994; 154: 1349-1352
        • Ringdal N
        • Whitney JG
        • Summerton L
        Problems with inhaler technique and patient preference for oral therapy: tablet zafirlukast vs. inhaled beclomethasone [abstract].
        Am J Respir Crit Care Med. 1998; 157: A416
        • Milgrom H
        • Bender B
        • Ackerson L
        • Bowry P
        • Smith B
        • Rand C
        Noncompliance and treatment failure in children with asthma.
        J Allergy Clin Immunol. 1996; 98: 1051-1057
        • Reiss TF
        • Chervinsky P
        • Dockhorn RJ
        • Shingo S
        • Seidenberg B
        • Edwards TB
        Montelukast, a once-daily leukotriene receptor antagonist, in the treatment of chronic asthma: a multicenter, randomized, double-blind trial.
        Arch Intern Med. 1998; 158: 1213-1220
        • Laviolette M
        • Malmstrom K
        • Lu S
        • Chervinsky P
        • Pujet JC
        • Peszek I
        • et al.
        Montelukast added to inhaled beclomethasone in treatment of asthma.
        Am J Respir Crit Care Med. 1999; 160: 1862-1868
        • Malmstrom K
        • Rodriguez-Gomez G
        • Guerra J
        • Villaran C
        • Pineiro A
        • Wei LX
        • et al.
        Oral montelukast, inhaled beclomethasone, and placebo for chronic asthma: a randomized, controlled trial.
        Ann Intern Med. 1999; 130: 487-495
        • Edelman JM
        • Milewski KA
        • Turpin JA
        • Santanello NC
        • Bird SR
        • Rader CR
        Effectiveness and safety of montelukast, a leukotriene receptor antagonist, compared to inhaled cromolyn in moderate asthmatic children ages 6 to 11 [abstract].
        J Allergy Clin Immunol. 1999; 103: S134
        • Volovitz B
        • Duenas-Meza E
        • Chmielewska-Szewczyk D
        • Kosa L
        • Astafieva NG
        • Villaran C
        • et al.
        Comparison of oral montelukast and inhaled cromolyn with respect to preference, satisfaction, and adherence: a multicenter, randomized, open-label, crossover study in children with mild to moderate persistent asthma.
        Curr Ther Res. 2000; 61: 490-507
        • Drazen JM
        • Boccuzzi SJ
        • Wogen J
        • Strub P
        • Jones C
        • Nelsen L
        • et al.
        Adherence to prescribed treatment for asthma [abstract].
        Am J Respir Crit Care Med. 2000; 161: A402
        • Sculpher MJ
        • Buxton MJ
        The episode-free day as a composite measure of effectiveness. An illustrative economic evaluation of formoterol versus salbutamol in asthma therapy.
        Pharmacoeconomics. 1993; 4: 345-352
        • Santanello NC
        • Zhang J
        • Seidenberg B
        • Reiss TF
        • Barber BL
        What are minimal important changes for asthma measures in a clinical trial?.
        Eur Respir J. 1999; 14: 23-27
        • Bukstein DA
        Practical approach to the use of outcomes in asthma. Traveling the road to better asthmatic care.
        Immunol Allergy Clin North Am. 1996; 16: 859-891
        • Santanello NC
        • Barber BL
        • Reiss TF
        • Friedman BS
        • Juniper EF
        • Zhang J
        Measurement characteristics of two asthma symptom diary scales for use in clinical trials.
        Eur Respir J. 1997; 10: 646-651
        • American Thoracic Society
        Standardization of spirometry 1994 update.
        Am J Respir Crit Care Med. 1995; 152: 1107-1136
        • Selvin S
        Statistical analysis of epidemiologic data.
        : Oxford University Press, New York1991
        • Gastwirth JL
        Statistical measures of earnings differentials.
        Am Statistician. 1975; 29: 32-35
        • Stine RA
        • Heyse JF
        Nonparametric estimates of overlap.
        Stat Med. 2001; 20: 215-236
        • Snedecor GW
        • Cochran WG
        Statistical methods.
        8th ed. : Iowa State University Press, Ames, Iowa1989
        • Global Initiative for Asthma
        Pocket guide for asthma management and prevention: a pocket guide for physicians and nurses.
        : National Institutes of Health, Bethesda, Md1998
        • Rutten-Van Molken MPMH
        • Van Doorslaer EKA
        • Jansen MCC
        • Van Essen-Zandvliet EE
        • Rutten FFH
        Cost effectiveness of inhaled corticosteroid plus bronchodilator therapy versus bronchodilatory monotherapy in children with asthma.
        Pharmacoeconomics. 1993; 4: 257-270
        • Teeter JG
        • Bleecker ER
        Relationship between airway obstruction and respiratory symptoms in adult asthmatics.
        Chest. 1998; 113: 272-277
        • Drazen JM
        • O'Brien J
        • Sparrow D
        • Weiss ST
        • Martins MA
        • Israel E
        • et al.
        Recovery of leukotriene E4 from the urine of patients with airway obstruction.
        Am Rev Respir Dis. 1992; 146: 104-108
        • Busse W
        • Raphael GD
        • Galant S
        • Kalberg C
        • Goode-Sellers S
        • Srebro S
        • et al.
        Low-dose fluticasone propionate compared with montelukast for first-line treatment of persistent asthma: a randomized clinical trial.
        J Allergy Clin Immunol. 2001; 107: 461-468
        • Kamada AK
        • Szefler SJ
        • Martin RJ
        • Boushey HA
        • Chinchilli VM
        • Drazen JM
        • et al.
        Issues in the use of inhaled glucocorticoids.
        Am J Respir Crit Care Med. 1996; 153: 1739-1748
        • Chervinsky P
        • van As A
        • Bronsky EA
        • Dockhorn R
        • Noonan M
        • LaForce C
        • et al.
        Fluticasone propionate aerosol for the treatment of adults with mild to moderate asthma.
        J Allergy Clin Immunol. 1994; 94: 676-683
        • Nash DB
        • Sullivan SD
        • Mackowiak J
        Optimizing quality of care and cost effectiveness in treating allergic rhinitis in a managed care setting.
        Am J Managed Care. 2000; 6: S3-S15
        • Wagner JS
        Inhaled steroids in children: Risks versus rewards.
        J Pediatr. 1998; 132: 381-383
        • Israel E
        • Banerjee TR
        • Fitzmaurice GM
        • Kotlov TV
        • LaHive K
        • Leboff MS
        Effects of inhaled glucocorticoids on bone density in premenopausal women.
        N Engl J Med. 2001; 345: 941-947