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

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• Recruitment Status: Withdrawn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

Tracking Information

• First Submitted Date: February 24, 2010
• First Posted Date: February 26, 2010
• Last Update Posted Date: February 22, 2012
• Study Start Date: Not Provided
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Allergen BioCube (ABC) Study Evaluating the Onset of Action of Fluticasone Furoate Nasal Spray and Olopatadine Nasal Spray Compared to Placebo
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Allergic Rhinitis

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: February 21, 2012): 0
• Original Estimated Enrollment (submitted: February 24, 2010): 120
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT01076439
• Other Study ID Numbers: 10-270-0006
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: ORA, Inc.
• Study Sponsor: ORA, Inc.
• Collaborators: Not Provided

Investigators

• Principal Investigator: H. J. Crampton, MD; ORA, Inc.

• PRS Account: ORA, Inc.
• Verification Date: February 2012