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

NCT00938613 | Completed Phase 2

• 2 other identifiers: CDX947CT001P2DS06001
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Seasonal Allergic Rhinitis

Keywords

SAR

Outcome Measures

Primary Outcomes (1)

• Total Nasal Symptom Score

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

Secondary Outcomes (3)

• 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

• 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

Study Arms (3)

Captisol-Enabled Budesonide

EXPERIMENTAL

32 ug/spray

Drug: Budesonide

Rhinocort Aqua

ACTIVE COMPARATOR

32 ug/spray

Drug: Budesonide

Placebo

PLACEBO COMPARATOR

posphate buffered saline

Drug: Placebo

Interventions

Budesonide DRUG

nasal spray, one spray per nostril at time 0

Also known as: CDX947, Captisol

Captisol-Enabled Budesonide

Placebo DRUG

nasal spray, one spray per nostril at time 0

Also known as: phosphate buffered saline solution

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 antibiotic therapy for acute conditions within 14 days prior to the Screening Visit and thereafter. Low doses of antibiotics taken for prophylaxis are permitted based on the judgment of the Investigator if therapy was started prior to the Screening Visit AND is expected to continue throughout the study.
• Non-vaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the Screening Visit.
• Exposure to systemic corticosteroids for any indication, chronic or intermittent (e.g., arthritis), during the 60 days preceding the Screening Visit, or presence of an underlying condition that can reasonably be expected to require treatment with corticosteroids during the course of the study.
• Use of topical corticosteroids in concentrations in excess of 1% hydrocortisone or equivalent for dermatological conditions within 30 days prior to the Screening Visit
• History of epilepsy or seizures
• History of coronary heart disease, uncontrolled hypertension, or other clinically significant cardiovascular disease.

Sponsors & Collaborators

• Ligand Pharmaceuticals: lead

Study Sites (1)

Allied Research International - Cetero Research

Mississauga, Ontario, L4W 1N2, Canada

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Budesonide; SBE4-beta-cyclodextrin

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Deepen Patel, MD

  Allied Research International - Cetero Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2009
• First Posted: July 14, 2009
• Study Start: February 1, 2007
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: October 4, 2012

Record last verified: 2012-10

Locations

CA (1)