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

NCT00940953 | Completed Phase 2

• 2 other identifiers: CDX313CT001P2DS07001
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Patient-rated Total Nasal Symptom Score

  10 mins, 20 mins, 30 mins, 40 mins, 60 mins, 90 mins, 120 mins and then every hour up to 10 hours post dose

Secondary Outcomes (2)

• Patient-rated Total Symptom Score

  10 mins, 20 mins, 30 mins, 40 mins, 60 mins, 90 mins, 120 mins and then every hour up to 10 hours post dose

• Patient-rated EEC-RQLQ assessment

  -0.75 hours, 2 hours, 6 hours and 10 hours post dose

Study Arms (3)

Captisol-Enabled Budesonide + Azelastine

EXPERIMENTAL

Drug: Budesonide + Azelastine

Rhinocort Aqua+Astelin

ACTIVE COMPARATOR

Drug: Budesonide + Azelastine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Budesonide + Azelastine DRUG

nasal spray, one spray per nostril at time 0 plus one spray Placebo

Also known as: CDX-313, Captisol

Captisol-Enabled Budesonide + Azelastine

Placebo DRUG

nasal spray, one spray per nostril from each of 2 bottles 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
• Patients must have documentation of a positive skin test within 12 months of screening to ragweed allergen defined by a positive case history and a positive skin prick and/or intradermal test for 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 according to a negative urine pregnancy test and must be using acceptable birth control methods
• In generally good health on the basis of medical history and physical examination.
• 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 (ova or sperm) for in-vitro fertilization
• Have clinically significant physical findings of nasal anatomical deformities causing greater than 50% obstruction based on the clinical estimate of the investigator, including nasal polyps, septal defects or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma, or surgery and atrophic rhinitis or rhinitis medicamentosa
• Previous participation in a budesonide study within 1 month prior to the Screening Visit.
• Currently participating in a clinical trial or has been exposed to an investigational treatment within the 30 days prior to the Screening Visit.
• A known hypersensitivity to any corticosteroid or any of the excipients in the formulation of the investigational drug (e.g., any adverse experience with budesonide, azelastine or the Captisol-containing products Vfend IV or Geodon IM).
• 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.
• Use of antibiotic therapy for acute conditions
• Initiation of immunotherapy or dose escalation during the study period.
• Non-vaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the Screening Visit.
• Exposure to systemic corticosteroids
• Use of topical corticosteroids in concentrations in excess of 1% hydrocortisone or equivalent
• 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; azelastine; 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 15, 2009
• First Posted: July 17, 2009
• Study Start: February 1, 2008
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: October 4, 2012

Record last verified: 2012-10

Locations

CA (1)