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

NCT00940953 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2012-10-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Ligand Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Deepen Patel, MD · Allied Research International - Cetero Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00940953 on ClinicalTrials.gov