NCT00940953

Compare Captisol-Enabled (CE) Budesonide + Azelastine Nasal Solution and Rhinocort Aqua + Astelin in an Environmental Exposure Chamber (EEC) Study of Allergic Rhinitis

A Randomized, Double-Blind, Placebo-Controlled, 3-Way Cross-Over Study Comparing Relative Efficacy of CE Budesonide+Azelastine & Rhinocort Aqua+Astelin Nasal Sprays Against Placebo in the Treatment of AR in an EEC Model

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (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 Placebo to Captisol-Enabled Budesonide + Azelastine in a single spray and two separate sprays (Budesonide + Azelastine) in patients with Seasonal Allergic Rhinitis exposed to controlled ragweed pollen.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Budesonide + Azelastine	nasal spray, one spray per nostril at time 0 plus one spray Placebo
DRUG	Budesonide + Azelastine	nasal spray, one spray of each per nostril at time 0
DRUG	Placebo	nasal spray, one spray per nostril from each of 2 bottles at time 0

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2009-07-17
• Last updated: 2012-10-04

Locations

1 site across 1 country: Canada