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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Recruitment Status : Withdrawn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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: Fluticasone Furoate Nasal Spray Drug: Olopatadine Nasal Spray Drug: Saline Nasal Spray Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Olopatadine Nasal Spray (Patanase) Drug: Olopatadine Nasal Spray
Olopatadine Nasal Spray: 2660mcg BID
Active Comparator: Fluticasone Furoate Nasal Spray (Veramyst) Drug: Fluticasone Furoate Nasal Spray
Fluticasone Furoate Nasal Spray: 110mcg QD
Placebo Comparator: Saline Nasal Spray (Placebo) Drug: Saline Nasal Spray
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Headaches [ Time Frame: Evaluated by the subject pre-ABC exposure, every 30 minutes during all ragweed exposures in the ABC, and post-ABC exposure ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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): NCT01076439


Sponsors and Collaborators
ORA, Inc.
Investigators
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Principal Investigator: H. J. Crampton, MD ORA, Inc.
More Information
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Responsible Party: ORA, Inc.
ClinicalTrials.gov Identifier: NCT01076439    
Other Study ID Numbers: 10-270-0006
First Posted: February 26, 2010    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Olopatadine Hydrochloride
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antirheumatic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents