A Placebo and Active Controlled Study of ONO-6950 Following Allergen Challenge in Patients With Asthma

Summary

The primary objectives are * to determine the effect of ONO-6950 200 mg QD versus placebo administered for 8 days on early asthmatic response (EAR) and late asthmatic response (LAR) induced by inhaled allergen * to determine the safety and tolerability of ONO-6950 200 mg QD administered for 8 days in patients with asthma The secondary objectives are: * to compare the effect of ONO-6950 versus montelukast on the % decrease of FEV1 following allergen exposure, and * to determine the effect of ONO-6950 versus placebo and montelukast on allergen-induced airway hyperresponsiveness (AHR) as measured by methacholine challenge

Timeline

Start

2012-06

Primary completion

2013-04

Completion

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Publications

• Gauvreau GM, Boulet LP, FitzGerald JM, Cockcroft DW, Davis BE, Leigh R, Tanaka M, Fourre JA, Tanaka M, Nabata T, O'Byrne PM. A dual CysLT1/2 antagonist attenuates allergen-induced airway responses in subjects with mild allergic asthma. Allergy. 2016 Dec;71(12):1721-1727. doi: 10.1111/all.12987. Epub 2016 Aug 9.

Drugs

Indications