NCT00758446

Efficacy and Safety Study of BLX-028914 in Subjects With Allergic Rhinitis

A Double-blind, Randomized, Placebo-controlled, Cross-over, Allergen Challenge Study to Evaluate the Efficacy, Safety and Tolerability of BLX-028914 in Subjects With Allergic Rhinitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Dart NeuroScience, LLC · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II study in patients with seasonal allergic rhinitis (SAR) and will compare the effect versus placebo of two different oral doses of BLX-028914 in an allergen challenge model. BLX-028914, a selective phosphodiesterase-4 (PDE4) inhibitor with a promising safety profile,is currently under development for treatment of airway diseases by Orexo AB, Sweden. The aim of this study is to compare the effect, safety and tolerability of 14 days treatment with BLX-0289014 in patients with SAR in an allergen challenge model versus placebo.

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	BLX-028914	50 mg capsules, p.o, daily, 14 days
DRUG	BLX-028914	15 mg capsules, p.o, daily, 14 days
DRUG	placebo	capsules, p.o, daily, 14 days

Timeline

• Start date: 2008-09-01
• Primary completion: 2008-12-01
• Completion: 2009-01-01
• First posted: 2008-09-25
• Last updated: 2013-03-13

Locations

1 site across 1 country: Sweden