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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ligand Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00940953
First received: July 15, 2009
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: Budesonide + Azelastine
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Ligand Pharmaceuticals:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]
  • Patient-rated EEC-RQLQ assessment [ Time Frame: -0.75 hours, 2 hours, 6 hours and 10 hours post dose ] [ Designated as safety issue: No ]

Enrollment: 108
Study Start Date: February 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Active Comparator: Rhinocort Aqua+Astelin Drug: Budesonide + Azelastine
nasal spray, one spray of each per nostril at time 0
Other Names:
  • Rhinocort Aqua
  • Astelin
Placebo Comparator: Placebo Drug: Placebo
nasal spray, one spray per nostril from each of 2 bottles at time 0
Other Name: phosphate buffered saline solution

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00940953

Locations
Canada, Ontario
Allied Research International - Cetero Research
Mississauga, Ontario, Canada, L4W 1N2
Sponsors and Collaborators
Ligand Pharmaceuticals
Investigators
Principal Investigator: Deepen Patel, MD Allied Research International - Cetero Research
  More Information

No publications provided

Responsible Party: Ligand Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00940953     History of Changes
Other Study ID Numbers: CDX313CT001, P2DS07001
Study First Received: July 15, 2009
Last Updated: October 2, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Pharmaceutical Solutions
Azelastine
Budesonide
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Lipoxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents

ClinicalTrials.gov processed this record on August 28, 2014