Official Title: “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”

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.

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Study Primary Completion Date: May 2008

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Captisol-Enabled Budesonide + Azelastine
• Active Comparator: Rhinocort Aqua+Astelin
• Placebo Comparator: Placebo

Primary Measures

• Patient-rated Total Nasal Symptom Score
  • Time Frame: 10 mins, 20 mins, 30 mins, 40 mins, 60 mins, 90 mins, 120 mins and then every hour up to 10 hours post dose
    Safety Issue?: No

Secondary Measures

• Patient-rated Total Symptom Score
  • Time Frame: 10 mins, 20 mins, 30 mins, 40 mins, 60 mins, 90 mins, 120 mins and then every hour up to 10 hours post dose
    Safety Issue?: No
• Patient-rated EEC-RQLQ assessment
  • Time Frame: -0.75 hours, 2 hours, 6 hours and 10 hours post dose
    Safety Issue?: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 any of the prohibited medications within the identified exclusion periods
• 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.
• Have any of the following conditions that are judged by the investigator to be clinically significant and/or affect the patient's ability to participate in the clinical trial:
• Impaired hepatic function including alcohol related liver disease or cirrhosis
• History of ocular disturbances (e.g., glaucoma or posterior subcapsular cataracts)
• Any systemic infection
• Hematological, renal, endocrine (except for controlled diabetes mellitis or postmenopausal symptoms or hypothyroidism)
• Gastrointestinal disease
• Malignancy (excluding basal cell carcinoma)
• A current neuropsychiatric condition with or without drug therapy

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: CyDex Pharmaceuticals, Inc.

Overall Clinical Trial Officials and Contacts

Deepen Patel, MD Principal Investigator Allied Research International - Cetero Research  

Information obtained from ClinicalTrials.gov on September 07, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00940953

Study ID Number: CDX313CT001

ClinicalTrials.gov Identifier: NCT00940953

Health Authority: Canada: Health Canada