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

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ClinicalTrials.gov Identifier: NCT00940953
Recruitment Status : Completed
First Posted : July 17, 2009
Last Update Posted : October 4, 2012
Information provided by (Responsible Party):
Ligand Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: Budesonide + Azelastine Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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
Study Start Date : February 2008
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Patient-rated EEC-RQLQ assessment [ Time Frame: -0.75 hours, 2 hours, 6 hours and 10 hours post dose ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00940953

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Canada, Ontario
Allied Research International - Cetero Research
Mississauga, Ontario, Canada, L4W 1N2
Sponsors and Collaborators
Ligand Pharmaceuticals
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Principal Investigator: Deepen Patel, MD Allied Research International - Cetero Research
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Responsible Party: Ligand Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00940953    
Other Study ID Numbers: CDX313CT001
First Posted: July 17, 2009    Key Record Dates
Last Update Posted: October 4, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Respiratory Tract Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Lipoxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists