A placebo-controlled, dose-ranging study of montelukast, a cysteinyl leukotriene–receptor antagonist

Altman, Leonard C.; Munk, Zev M.; Seltzer, James M.; Noonan, Nancy; Shingo, Sumiko; Zhang, Ji; Reiss, Theodore F.

doi:10.1016/s0091-6749(98)70054-5

Cited by 138 publications

(96 citation statements)

References 19 publications

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“…Our data confirm the different antiinflammatory effects ofbudesonide and montelukast in the treatment of mild-persistent asthma, showing a greater efficacy of montelukast in modifying significantly the respiratory function parameters studied (FEVI and FVC) by selectively blocking the binding to the receptors ofleukotrienes, among the most powerful bronchoconstrictor agents (12,13). Furthermore, a consistent improvement in QoL has been observed in all domains, with particular reference to the physical activity and environmental exposure ones, but also, even though with less statistical significance, in symptoms and emotions domain.…”

Section: Discussionsupporting

confidence: 83%

Effectiveness of Montelukast versus Budesonide on Quality of Life and Bronchial Reactivity in Subjects with Mild-Persistent Asthma

Riccioni

Ballone

D’Orazio

et al. 2002

Int J Immunopathol Pharmacol

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Insufficient data exist to evaluate the comparative effects of inhaled corticosteroids (ICS) versus leukotriene receptor antagonist (LTRA) on airway inflammation and quality of life (QoL). The aim of the study was to compare the effectiveness of montelukast compared to budesonide at different doses on QoL and bronchial reactivity in mild-asthmatic adult patients. 45 subjects with bronchial asthma were randomly assigned to a different treatment and divided in 3 treatment groups: A: 400 μg of budesonide twice a day; B: 10 mg of montelukast daily; C: 10 mg of montelukast daily plus 400 μg of budesonide twice a day. At the beginning of the study and at the end of the treatment period (16 weeks) all patients underwent complete clinical evaluation, pulmonary function testing and methacholine challenge test (MCHt). In group A the increase from baseline was 153.4%, in group C was 133.2%, and in group B 247.7%, the latter increase being statistically significant compared to that in the other 2 groups (p< 0.005 Wilcoxon test). In all domains the improvement in quality of life in the group treated with montelukast (group B) was significantly greater than that in the group treated with both medications (group C): in particular, the improvement was consistent in the symptoms (p< 0.01) and emotions (p< 0.01) domains, and weaker in the physical activity (p< 0.05). A similar difference was observed between group B and A, but only in the symptoms (p<0.01), emotions (p<0.01), and environmental stimuli domains (p<0.05). The personal perception of their own disease is important for a correct therapeutic management of asthma. In order to optimize the treatment, a complete adherence of the patient to the treatment itself is required, to be achieved through simplification of therapeutic schedule and easy administration of medications. Montelukast may be considered a valid alternative in the treatment of mild-persistent asthma, both for the clinical and functional benefits and for the great advantage of the once-daily dosage, which consistently improves the compliance with the chronic treatment of the disease.

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Section: Discussionsupporting

confidence: 83%

Effectiveness of Montelukast versus Budesonide on Quality of Life and Bronchial Reactivity in Subjects with Mild-Persistent Asthma

Riccioni

Ballone

D’Orazio

et al. 2002

Int J Immunopathol Pharmacol

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“…The current results would suggest a plateau in the doseresponse for ML at 10 mg, which is the conventional recommended dose [19]. This is perhaps surprising given the overproduction of cysteinyl leukotrienes in AIA [1,[3][4][5][6][7][8].…”

Section: Discussionmentioning

confidence: 63%

Montelukast protects against nasal lysine-aspirin challenge in patients with aspirin-induced asthma

Lee¹,

Haggart²,

Robb³

et al. 2004

Eur Respir J

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Aspirin-induced asthma (AIA) is associated with increased production of cysteinyl leukotrienes (CysLT). Although leukotriene CysLT 1 -receptor antagonists improve lower airway outcomes in AIA, their effects and dose-response in the upper airway is less well documented.The present study evaluated the dose-response for montelukast (ML) against nasal lysine-aspirin challenge in patients with AIA.A total of 12 patients with a clear-cut history of AIA were randomised in double-blind cross-over fashion to receive single doses of ML 10 mg, ML 40 mg, or placebo (PL), with nasal lysine-aspirin challenge performed 12 h after dosing. Measurements of peak nasal inspiratory flow (PNIF), nasal blockage visual analogue scale (VAS) and forced expiratory volume in one second (FEV1) were made over 120 min after nasal lysineaspirin challenge.Prechallenge values for mean¡SEM PNIF (L?min -1 ) were not significantly different comparing all groups: ML 10 mg (132¡10), ML 40 mg (125¡12) and PL (132¡11). There was no significant difference comparing the maximum % PNIF fall from baseline between screening (46¡6) and PL (45¡6). The maximum % PNIF fall from baseline was significantly greater with PL (45¡6) compared to either ML 10 mg (34¡6) or ML 40 mg (32¡5). There was also a significantly greater mean % PNIF response over 120 min after lysine-aspirin challenge for PL (26¡7) compared to either ML 10 mg (14¡6) or ML 40 mg (17 ¡ 6). There were no significant differences for the maximum or mean % PNIF fall from baseline comparing ML 10 mg and ML 40 mg. A significant increase in nasal blockage VAS score was observed between baseline and 60 min or 120 min with PL but not with ML 10 mg or ML 40 mg. There were no significant differences for either the maximum or mean % FEV1 over 120 min as change from baseline comparing all groups.A single 10 mg dose of montelukast partially protected against the local effects of nasal lysine-aspirin challenge, with no further benefit at 40 mg. Nasal lysine-aspirin challenge appeared to be a reproducible and safe method in assessing patients with aspirin-induced asthma.

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“…This is a consideration for future study. However, against this possibility are the observations of ALTMAN et al [22] who found, in a dose-ranging study in moderate-to-severe asthma (FEV1 59-62% predicted), that montelukast 10 mg daily, over 6 weeks, produced similar improvement to doses of 100 or 200 mg in blood eosinophil counts, symptoms, FEV1 and PEF. With respect to duration of treatment, there has been no study in subjects needing higher doses of corticosteroid treatment.…”

Section: Discussionmentioning

confidence: 99%

Failure of montelukast to reduce sputum eosinophilia in high-dose corticosteroid-dependent asthma

Jayaram¹

2005

Eur Respir J

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Sputum eosinophilia is a sensitive predictor of benefit from corticosteroid treatment. Montelukast is a cysteinyl leukotriene antagonist, which also reduces sputum and blood eosinophils. The present study examined the possibility that montelukast has an added eosinophil-lowering effect in subjects with asthma who are corticosteroid responsive but relatively corticosteroid resistant.A total of 14 clinically stable adults with asthma requiring minimum treatment with a high-dose inhaled steroid or prednisone, with baseline sputum eosinophilia (o5%), were randomised to receive 4 weeks of 10 mg montelukast or placebo daily in a double-blind crossover trial. The primary outcome was the effect of treatment on the percentage of sputum eosinophils. Secondary outcomes were changes in the blood eosinophil count, symptoms, forced expiratory volume in one second, peak expiratory flow and the need for salbutamol.The median (interquartile range, i.e. 75th-25th centile) for sputum eosinophils at baseline was 15.7% (22). The effect of adding montelukast was not significantly different from that of placebo, sputum eosinophils being 9.3% (18.9) after montelukast and 11.3% (22.8) after placebo. No difference was detected on secondary outcomes. No crossover interactions were observed.In conclusion, the addition of montelukast to existing high-dose corticosteroid therapy in subjects with asthma with elevated sputum eosinophils does not provide additional attenuation of airway eosinophilia.

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A placebo-controlled, dose-ranging study of montelukast, a cysteinyl leukotriene–receptor antagonist

Cited by 138 publications

References 19 publications

Effectiveness of Montelukast versus Budesonide on Quality of Life and Bronchial Reactivity in Subjects with Mild-Persistent Asthma

Effectiveness of Montelukast versus Budesonide on Quality of Life and Bronchial Reactivity in Subjects with Mild-Persistent Asthma

Montelukast protects against nasal lysine-aspirin challenge in patients with aspirin-induced asthma

Failure of montelukast to reduce sputum eosinophilia in high-dose corticosteroid-dependent asthma

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