Results of the First U.S. Double-Blind, Placebo-Controlled, Multicenter Clinical Study in Asthma with Pranlukast, a Novel Leukotriene Receptor Antagonist

Grossman, Jay; Faiferman, Isidore; Dubb, Jeffrey W.; Tompson, Debra J.; Busse, William W.; Bronsky, Edwin A.; Montanaro, Anthony; Southern, L; Tinkelman, David G.

doi:10.3109/02770909709067222

Cited by 70 publications

(33 citation statements)

References 10 publications

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“…[109][110][111] Use of these agents improves baseline lung function, reduces symptoms, and lessens the requirement for rescue medications. High-dose zafirlukast therapy for 6 weeks significantly improved asthma control over placebo in patients who were refractory to high-dose inhaled corticosteroid therapy.…”

Section: Cysteinyl Lt Receptor Antagonists In Clinical Asthmamentioning

confidence: 99%

Role of leukotrienes in asthma pathophysiology

Bisgaard

2000

Pediatr. Pulmonol.

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Section: Cysteinyl Lt Receptor Antagonists In Clinical Asthmamentioning

confidence: 99%

Role of leukotrienes in asthma pathophysiology

Bisgaard

2000

Pediatr. Pulmonol.

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“…Pranlukast (8-[p-(4-phenylbutyloxy)benzol] amino-2-[tetrazol-5-yl]-4-oxo-4H-1-benzopyran hemihydrate) is a selective cysLT 1 receptor antagonist [7]. It is effective in reducing bronchial hyperresponsiveness and allergen-induced bronchoconstriction.…”

Section: Introductionmentioning

confidence: 99%

Pranlukast Inhibits NF-κB Activation and <i>MUC2</i> Gene Expression in Cultured Human Epithelial Cells

et al. 2005

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Pranlukast is a selective cysteinyl leukotriene₁(cysLT₁) receptor antagonist, and is now widely used in the treatment of asthma. The anti-asthmatic effect of pranlukast may be rendered not only by antileukotriene activity, but also by other pharmacological activity. This study was designed to investigate whether pranlukast had inhibitory effects on nuclear factor-ĸB (NF-ĸB) activation and mucin gene expression in cultured human epithelial cells. Luciferase assay was mainly used for analysis. Cultured epithelial cells were transfected with NF-ĸB luciferase vector, MUC2 or MUC5AC luciferase vectors. Lipopolysaccharide (LPS) significantly increased NF-ĸB activation in NCI-H292 cells, which was inhibited by the pretreatment by pranlukast in a dose-dependent manner. Either LTD₄ or pranlukast alone did not increase NF-ĸB activation in NCI-H292 cells. Pranlukast also inhibited NF-ĸB activation induced by phorbol 12-myristate 13-acetate (PMA). Pranlukast also significantly inhibited LPS-induced MUC2 mRNA expression by reverse transcription-polymerase chain reaction (RT-PCR) analysis in NCI-H292 cells. Pranlukast also inhibited LPS-induced MUC2 gene expression in HM3-MUC2 cells. However, pranlukast did not inhibit MUC5AC gene transcription activity induced by lipoteichoic acid (LTA) in NCI-H292 cells. These results suggest that pranlukast may inhibit NF-ĸB activation and MUC2 gene transcription through pathways distinct from cysLT₁ receptor antagonism in cultured human epithelial cells.

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“…Thus, LTRA decreases airway inflammation by suppression of LT action [7, 8]. Different reports have shown that treatment of persistent asthmatics with LTRA resulted in 6–14% (in the range) improvement of forced expiratory volume in 1 s (FEV 1 ) and/or peak expiratory flow rate (PEFR), and decreases of 19–46% in nocturnal symptoms, 13–27% in daytime symptom score and 10–31% in the use of rescue β 2 -agonists [9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20]. Based on these studies, the revised versions of the Global Initiative for Asthma published in 1998 and 2002, respectively, both recognize LTRA in combination with corticosteroids as a maintenance therapy in the treatment of asthma [2].…”

Section: Introductionmentioning

confidence: 99%

The Position of Pranlukast, a Cysteinyl Leukotriene Receptor Antagonist, in the Long-Term Treatment of Asthma

Obase

Shimoda²,

Matsuse³

et al. 2004

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Background: Adverse effects, tachyphylaxis, and the position of pranlukast, a cysteinyl leukotriene receptor antagonist, in asthma treatment have not been fully established. Objectives and Methods: To address these questions, adverse effects and long-term efficacy of pranlukast were evaluated in 82 patients [28 patients with moderate asthma (group I), 27 with severe persistent asthma not on oral corticosteroid (OCS; group II) and 27 with severe persistent asthma on OCS (group III)] at 4 and 16 weeks. In the following, pranlukast was either withdrawn 1 year after the start of therapy, or if that was not possible due to reappearance of symptoms, the dose of OCS or inhaled corticosteroid (ICS) was reduced. The efficacy of pranlukast was evaluated during 5 years by peak expiratory flow rate (PEFR), and symptom and treatment scores. Results: Adverse reactions appeared in 4 patients (4.9%; diarrhea, dizziness and leg edema). The mean improvement in PEFR on week 16 was 18.5 ± 2.3, 18.8 ± 3.2, and 15.2 ± 3.8% in groups I–III, respectively (p < 0.01, for all groups). However, increases in PEFR in 29 of 72 patients (40.3%) were less than 15%. Pranlukast could not be withdrawn in 28 of 42 responders (66.7%), but their dose of ICS was reduced by 363 ± 97 µg/day (group II) and that of OCS by 3.4 ± 0.7 mg/day (group III). Tachyphylaxis was not recognized during the 5-year period. Conclusion: Pranlukast is safe when taken for up to 5 years, and is effective irrespective of asthma severity. In the majority of patients with persistent asthma, pranlukast may help to control the disease in the long term.

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Results of the First U.S. Double-Blind, Placebo-Controlled, Multicenter Clinical Study in Asthma with Pranlukast, a Novel Leukotriene Receptor Antagonist

Cited by 70 publications

References 10 publications

Role of leukotrienes in asthma pathophysiology

Role of leukotrienes in asthma pathophysiology

Pranlukast Inhibits NF-κB Activation and <i>MUC2</i> Gene Expression in Cultured Human Epithelial Cells

The Position of Pranlukast, a Cysteinyl Leukotriene Receptor Antagonist, in the Long-Term Treatment of Asthma

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