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

Ligand Pharmaceuticals1 site in 1 country65 target enrollmentFebruary 2007

ConditionsSeasonal Allergic Rhinitis

InterventionsBudesonide Placebo

DrugsBudesonide Placebo

Overview

Phase: Phase 2
Intervention: Budesonide
Conditions: Seasonal Allergic Rhinitis
Sponsor: Ligand Pharmaceuticals
Enrollment: 65
Locations: 1
Primary Endpoint: Total Nasal Symptom Score
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

February 2007

End Date

April 2007

Last Updated

13 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Ligand Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must have a clinical history of SAR
•Adults (males and females) aged 18 to 65, inclusive
•Patients must have documentation of a positive skin test within 12 months of screening to ragweed allergen
•Non-pregnant, non-lactating females, or women who are post-menopausal or are naturally or surgically sterile. Females of childbearing potential must have a confirmed absence of pregnancy and must be using an acceptable birth control method
•In generally good health
•Willingness to attend all study visits
•Capable of following and understanding instructions
•Willing and able to provide written informed consent prior to initiation of any study procedures, including initiation of washout of any concomitant medications

Exclusion Criteria

•Pregnancy, nursing, or plans to become pregnant or donate gametes
•Have clinically significant physical findings of nasal anatomical deformities causing greater than 50% obstruction
•Previous participation in a budesonide study within three months prior to the Screening Visit.
•Participation in any investigational drug trial within the 30 days preceding the Screening Visit, and thereafter.
•A known hypersensitivity to any corticosteroid or any of the excipients in the formulation of the investigational drug
•History of severe respiratory infection or disorder
•History of alcohol or drug abuse
•History of a positive test for HIV, hepatitis B or hepatitis C.
•Active asthma requiring treatment with inhaled or systemic corticosteroid and/or routine use of ß-agonists or any controller drugs, intermittent use (less than or equal to 3 uses per week) of inhaled short acting ß-agonists is acceptable.
•Use of any of the prohibited medications within the identified exclusion periods

Arms & Interventions

Captisol-Enabled Budesonide

32 ug/spray

Intervention: Budesonide

Rhinocort Aqua

32 ug/spray

Intervention: Budesonide

Placebo

posphate buffered saline

Intervention: Placebo

Outcomes

Primary Outcomes

Total Nasal Symptom Score

Time Frame: 15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins, and then every hour up to 10 hours post dose

Secondary Outcomes

Compare the effect and of the three treatments on an EEC-Specific Quality of Life questionnaire(-0.75, 2, 6 and 10 hours post-dose)
Onset of action of active treatments as compared to placebo(15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins and then every hour up to 10 hours post dose)
Compare the tolerance as measured by subject questionnaire and adverse events of Captisol-Enabled Budesonide nasal solution, Rhinocort Aqua and Placebo(15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins, and then every hour up to 10 hours post dose)