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Compare CE-Budesonide Nasal Solution & Rhinocort Aqua in an EEC Study of AR

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ligand Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00938613
First received: July 13, 2009
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

The primary objective of this study was to compare the relative efficacy of Budesonide administered via Captisol-Enabled Budesonide nasal solution and Rhinocort Aqua in patients with seasonal allergic rhinitis (SAR) exposed to controlled ragweed pollen using an EEC model.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: Budesonide
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 to Compare the Relative Efficacy of Budesonide Administered Via CE Budesonide Nasal Solution & Rhinocort Aqua in the Treatment of the Symptoms of AR in an EEC Model

Resource links provided by NLM:


Further study details as provided by Ligand Pharmaceuticals:

Primary Outcome Measures:
  • Total Nasal Symptom Score [ Time Frame: 15 mins, 30 mins, 45 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:
  • Onset of action of active treatments as compared to placebo [ Time Frame: 15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins and then every hour up to 10 hours post dose ] [ Designated as safety issue: No ]
  • Compare the tolerance as measured by subject questionnaire and adverse events of Captisol-Enabled Budesonide nasal solution, Rhinocort Aqua and Placebo [ Time Frame: 15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins, and then every hour up to 10 hours post dose ] [ Designated as safety issue: No ]
  • Compare the effect and of the three treatments on an EEC-Specific Quality of Life questionnaire [ Time Frame: -0.75, 2, 6 and 10 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: February 2007
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Captisol-Enabled Budesonide
32 ug/spray
Drug: Budesonide
nasal spray, one spray per nostril at time 0
Other Names:
  • CDX947
  • Captisol
Active Comparator: Rhinocort Aqua
32 ug/spray
Drug: Budesonide
nasal spray, one spray per nostril at time 0
Other Name: Rhinocort Aqua
Placebo Comparator: Placebo
posphate buffered saline
Drug: Placebo
nasal spray, one spray per nostril at time 0
Other Name: phosphate buffered saline solution

Detailed Description:

A Randomized, Double-Blind, Placebo-Controlled, Single-Center, Three-Way Cross-Over Study to Compare the Relative Efficacy of Budesonide administered via Captisol-Enabled® Budesonide Nasal Solution and Rhinocort Aqua® (32 µg/spray) in the Treatment of the Symptoms of Allergic Rhinitis in an Environmental Exposure Chamber (EEC).

  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, inclusive
  • Patients must have documentation of a positive skin test within 12 months of screening to 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 and must be using an acceptable birth control method
  • In generally good health
  • 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
  • Have clinically significant physical findings of nasal anatomical deformities causing greater than 50% obstruction
  • Previous participation in a budesonide study within three months prior to the Screening Visit.
  • Participation in any investigational drug trial within the 30 days preceding the Screening Visit, and thereafter.
  • A known hypersensitivity to any corticosteroid or any of the excipients in the formulation of the investigational drug
  • 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.
  • Active asthma requiring treatment with inhaled or systemic corticosteroid and/or routine use of ß-agonists or any controller drugs, intermittent use (less than or equal to 3 uses per week) of inhaled short acting ß-agonists is acceptable.
  • Use of any of the prohibited medications within the identified exclusion periods
  • Use of antibiotic therapy for acute conditions within 14 days prior to the Screening Visit and thereafter. Low doses of antibiotics taken for prophylaxis are permitted based on the judgment of the Investigator if therapy was started prior to the Screening Visit AND is expected to continue throughout the study.
  • Initiation of immunotherapy or dose escalation during the study period. However, patients may be considered for inclusion if the immunotherapy was initiated 90 days or more prior to the Screening Visit AND if the dosing was stable (maintenance dose) for 30 days or more prior to the Screening Visit. No immunotherapy injections may be received within 48 hours prior to a ragweed pollen exposure visit.
  • Non-vaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the Screening Visit.
  • Exposure to systemic corticosteroids for any indication, chronic or intermittent (e.g., arthritis), during the 60 days preceding the Screening Visit, or presence of an underlying condition that can reasonably be expected to require treatment with corticosteroids during the course of the study.
  • Use of topical corticosteroids in concentrations in excess of 1% hydrocortisone or equivalent for dermatological conditions within 30 days prior to the Screening Visit
  • 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: NCT00938613

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: NCT00938613     History of Changes
Other Study ID Numbers: CDX947CT001, P2DS06001
Study First Received: July 13, 2009
Last Updated: October 2, 2012
Health Authority: Canada: Health Canada

Keywords provided by Ligand Pharmaceuticals:
SAR

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Rhinitis
Budesonide
Pharmaceutical Solutions
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014