Results of the first U.S. double-blind, placebo-controlled, multicenter clinical study in asthma with Pranlukast, a novel leukotriene receptor antagonist

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

Research output: Contribution to journalArticle

70 Citations (Scopus)

Abstract

Pranlukast (SB 205312; ONO-1078), a potent, orally active selective cysteinyl-leukotriene receptor antagonist (LTRA), was developed in Japan for the treatment of asthma. This article reports results of the initial U.S. clinical evaluation of pranlukast. The primary objective of this multicenter study was to evaluate the safety and tolerability of pranlukast administered at doses of 337.5 mg b.i.d. and 450 mg b.i.d. in 65 patients with mild to moderate asthma. Pranlukast, a novel LTRA, is safe and well tolerated at doses of 337.5 mg b.i.d. and 450 mg b.i.d. Pranlukast has demonstrated clinical activity in patients with asthma.

Original languageEnglish (US)
Pages (from-to)321-328
Number of pages8
JournalJournal of Asthma
Volume34
Issue number4
StatePublished - 1997
Externally publishedYes

Fingerprint

Leukotriene Antagonists
Multicenter Studies
Asthma
Placebos
Clinical Studies
pranlukast
Japan
Safety

Keywords

  • Asthma
  • Clinical trial
  • Leukotriene receptor antagonist
  • ONO-1078
  • Pranlukast
  • SB 205312

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

Grossman, J., Faiferman, I., Dubb, J. W., Tompson, D. J., Busse, W., Bronsky, E., ... Tinkelman, D. (1997). Results of the first U.S. double-blind, placebo-controlled, multicenter clinical study in asthma with Pranlukast, a novel leukotriene receptor antagonist. Journal of Asthma, 34(4), 321-328.

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; Bronsky, Edwin; Montanaro, Anthony; Southern, Loren; Tinkelman, David.

In: Journal of Asthma, Vol. 34, No. 4, 1997, p. 321-328.

Research output: Contribution to journalArticle

Grossman, J, Faiferman, I, Dubb, JW, Tompson, DJ, Busse, W, Bronsky, E, Montanaro, A, Southern, L & Tinkelman, D 1997, 'Results of the first U.S. double-blind, placebo-controlled, multicenter clinical study in asthma with Pranlukast, a novel leukotriene receptor antagonist', Journal of Asthma, vol. 34, no. 4, pp. 321-328.
Grossman, Jay ; Faiferman, Isidore ; Dubb, Jeffrey W. ; Tompson, Debra J. ; Busse, William ; Bronsky, Edwin ; Montanaro, Anthony ; Southern, Loren ; Tinkelman, David. / Results of the first U.S. double-blind, placebo-controlled, multicenter clinical study in asthma with Pranlukast, a novel leukotriene receptor antagonist. In: Journal of Asthma. 1997 ; Vol. 34, No. 4. pp. 321-328.
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