An Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo

Overview

The purpose of this study is to evaluate the onset of action of fluticasone propionate nasal spray compared to placebo nasal spray in reducing nasal allergic signs and symptoms following ragweed exposure in the Allergen BioCube (ABC) after up to 14 days of at home dosing.

Full Title of Study: “A Single-Center, Randomized, Double-Masked, Placebo-Controlled Evaluation of the Efficacy of Flonase (Fluticasone Propionate Nasal Spray) Compared to Placebo Nasal Spray in the Allergen BioCube (ABC) Model”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: October 2011

Interventions

  • Drug: Fluticasone Propionate Nasal Spray
    • 50 mcg QD
  • Drug: Saline Nasal Spray
    • two sprays in each nostril once daily

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo Nasal Spray
  • Active Comparator: Fluticasone Propionate

Clinical Trial Outcome Measures

Primary Measures

  • Nasal Signs and Symptoms (TNSS)
    • Time Frame: approximately 3 weeks
    • TNSS (0-12 unit scale) is defined as the sum of the four nasal symptom scores recorded for nasal itching, sneezing, rhinorrhea and nasal congestion. Evaluated by the subject pre-ABC exposure, every 15 minutes during all ragweed exposures in the ABC, and post-ABC exposure at Visits 2, 3, 4, and 5 which will occur over approximately 3 weeks

Secondary Measures

  • Nasal Itching
    • Time Frame: Evaluated by the subject pre-ABC exposure, every 15 minutes during all ragweed exposures in the ABC, and post-ABC exposure at Visits 2, 3, 4, and 5 which will occur over approximately 3 weeks
  • Sneezing
    • Time Frame: Evaluated by the subject pre-ABC exposure, every 15 minutes during all ragweed exposures in the ABC, and post-ABC exposure at Visits 2, 3, 4, and 5 which will occur over approximately 3 weeks
  • Rhinorrhea
    • Time Frame: Evaluated by the subject pre-ABC exposure, every 15 minutes during all ragweed exposures in the ABC, and post-ABC exposure at Visits 2, 3, 4, and 5 which will occur over approximately 3 weeks
  • Nasal Congestion
    • Time Frame: Evaluated by the subject pre-ABC exposure, every 15 minutes during all ragweed exposures in the ABC, and post-ABC exposure at Visits 2, 3, 4, and 5 which will occur over approximately 3 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • provide written informed consent and signed HIPAA form;
  • be able and willing to follow all instructions and attend the study visits;
  • if female and of childbearing potential, be not pregnant, nursing or planning a pregnancy, be willing to submit a pregnancy test at Visit 1 and at exit visit, and to use adequate method of birth control
  • have a positive history of seasonal allergic rhinitis to ragweed;
  • have a positive skin test reaction to ragweed of within the past 24 months;
  • manifest sufficient allergic rhinitis symptoms during ragweed exposure in the ABC

Exclusion Criteria

  • known intolerance or allergy to antihistamines or corticosteroids;
  • have a compromised lung function at Visit 1;
  • develop a compromised lung function at Visits 2-6
  • have any presence of active sinus or nasal infection at any visit;
  • have experienced an acute upper or lower respiratory tract infection or acute sinusitis within 30 days of visit 1;
  • have significant nasal anatomical deformities or any condition that does not allow subject to breathe through the nose (includes, but is not limited to: septal deviation, septal perforations, nasal polyps, rhinitis medicamentosa)
  • have had any nasal surgical intervention in the past;
  • have a known history of glaucoma
  • have planned surgery (nasal, ocular or systemic) during the trial period or within 30 days thereafter;
  • inability or refusal to discontinue contact lens wear during all visits;
  • use disallowed medications during the study or appropriate pre-study washout period

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ORA, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Tarek Shazly, MD, Principal Investigator, ORA, Inc.

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