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

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 Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: Budesonide + Azelastine; Drug: Budesonide + Azelastine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L4W 1N2
      • Allied Research International - Cetero Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; nasal spray, one spray per nostril from each of 2 bottles at time 0; Other Names: phosphate buffered saline solution
Experimental: Captisol-Enabled Budesonide + Azelastine	Drug: Budesonide + Azelastine; nasal spray, one spray per nostril at time 0 plus one spray Placebo; Other Names: CDX-313; Captisol; Drug: Budesonide + Azelastine; nasal spray, one spray of each per nostril at time 0; Other Names: Rhinocort Aqua; Astelin
Active Comparator: Rhinocort Aqua+Astelin	Drug: Budesonide + Azelastine; nasal spray, one spray per nostril at time 0 plus one spray Placebo; Other Names: CDX-313; Captisol; Drug: Budesonide + Azelastine; nasal spray, one spray of each per nostril at time 0; Other Names: Rhinocort Aqua; Astelin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ligand Pharmaceuticals
• Investigators: Principal Investigator: Deepen Patel, MD, Allied Research International - Cetero Research

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: July 15, 2009
• First Submitted That Met QC Criteria: July 16, 2009
• First Posted (Estimate): July 17, 2009

Study Record Updates

• Last Update Posted (Estimate): October 4, 2012
• Last Update Submitted That Met QC Criteria: October 2, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Lipoxygenase Inhibitors; Budesonide; Azelastine
• Other Study ID Numbers: CDX313CT001; P2DS07001