NCT00938613

Compare CE-Budesonide Nasal Solution & Rhinocort Aqua in an EEC Study of AR

A Randomized, Double-Blind, Placebo-Controlled, 3-Way Cross-Over Study to Compare the Relative Efficacy of Budesonide Administered Via CE Budesonide Nasal Solution & Rhinocort Aqua in the Treatment of the Symptoms of AR in an EEC Model

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Ligand Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study was to compare the relative efficacy of Budesonide administered via Captisol-Enabled Budesonide nasal solution and Rhinocort Aqua in patients with seasonal allergic rhinitis (SAR) exposed to controlled ragweed pollen using an EEC model.

Detailed description

A Randomized, Double-Blind, Placebo-Controlled, Single-Center, Three-Way Cross-Over Study to Compare the Relative Efficacy of Budesonide administered via Captisol-Enabled® Budesonide Nasal Solution and Rhinocort Aqua® (32 µg/spray) in the Treatment of the Symptoms of Allergic Rhinitis in an Environmental Exposure Chamber (EEC).

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Budesonide	nasal spray, one spray per nostril at time 0
DRUG	Placebo	nasal spray, one spray per nostril at time 0
DRUG	Budesonide	nasal spray, one spray per nostril at time 0

Timeline

• Start date: 2007-02-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2009-07-14
• Last updated: 2012-10-04

Locations

1 site across 1 country: Canada