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An Allergen BioCube (ABC) Study Evaluating the Onset of Action of Fluticasone Furoate Nasal Spray and Olopatadine Nasal Spray Compared to Placebo

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ClinicalTrials.gov Identifier: NCT01076439
Recruitment Status : Withdrawn
First Posted : February 26, 2010
Last Update Posted : February 22, 2012
Sponsor:
Information provided by (Responsible Party):
ORA, Inc.

Tracking Information
First Submitted Date  ICMJE February 24, 2010
First Posted Date  ICMJE February 26, 2010
Last Update Posted Date February 22, 2012
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2010)
Nasal Signs and Symptoms (TNSS) [ Time Frame: Evaluated by the subject pre-ABC exposure, every 15 minutes during all ragweed exposures in the ABC, and post-ABC exposure ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2010)
  • Peak Expiratory Flow Rate (PEFR) [ Time Frame: Measured pre-ABC exposure, every 30 minutes during all ragweed exposures in the ABC, and post-ABC exposure ]
  • Peak Nasal Inspiratory Flow (PNIF) [ Time Frame: Measured pre-ABC exposure, every 30 minutes during all ragweed exposures in the ABC, and post-ABC exposure ]
  • Headaches [ Time Frame: Evaluated by the subject pre-ABC exposure, every 30 minutes during all ragweed exposures in the ABC, and post-ABC exposure ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Allergen BioCube (ABC) Study Evaluating the Onset of Action of Fluticasone Furoate Nasal Spray and Olopatadine Nasal Spray Compared to Placebo
Official Title  ICMJE A Pilot Study Evaluating the Onset of Action of Fluticasone Furoate Nasal Spray and Olopatadine Nasal Spray Compared to Placebo Nasal Spray in Reducing Nasal Allergic Symptoms Following Ragweed Exposure in the Allergen BioCube (ABC)
Brief Summary The purpose of this study is to evaluate the onset of action of fluticasone furoate nasal spray compared to olopatadine nasal spray and placebo nasal spray in reducing nasal allergic signs and symptoms following ragweed exposure in the Allergen BioCube (ABC) after single dose administration and six consecutive days of treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Allergic Rhinitis
Intervention  ICMJE
  • Drug: Fluticasone Furoate Nasal Spray
    Fluticasone Furoate Nasal Spray: 110mcg QD
  • Drug: Olopatadine Nasal Spray
    Olopatadine Nasal Spray: 2660mcg BID
  • Drug: Saline Nasal Spray
    Placebo
Study Arms  ICMJE
  • Active Comparator: Olopatadine Nasal Spray (Patanase)
    Intervention: Drug: Olopatadine Nasal Spray
  • Active Comparator: Fluticasone Furoate Nasal Spray (Veramyst)
    Intervention: Drug: Fluticasone Furoate Nasal Spray
  • Placebo Comparator: Saline Nasal Spray (Placebo)
    Intervention: Drug: Saline Nasal Spray
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 21, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2010)
120
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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:

  • manifest symptoms of clinically active allergic rhinitis at the start of Visit 1 or Visit 2;
  • known intolerance or allergy to antihistamines or corticosteroids;
  • have a compromised lung function at 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 planned surgery (nasal, ocular or systemic) during the trial period or within 30 days thereafter;
  • use disallowed medications (topical, topical ophthalmic, systemic and/or injectable treatments and all anti-allergy therapies including prescription, over the counter or homeopathy, and over the counter sleeping aids) during the study or appropriate pre-study washout period
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01076439
Other Study ID Numbers  ICMJE 10-270-0006
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ORA, Inc.
Study Sponsor  ICMJE ORA, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: H. J. Crampton, MD ORA, Inc.
PRS Account ORA, Inc.
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP