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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
ORA, Inc.
ClinicalTrials.gov Identifier:
NCT01076439
First received: February 24, 2010
Last updated: February 21, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Allergic Rhinitis
Drug: Fluticasone Furoate Nasal Spray
Drug: Olopatadine Nasal Spray
Drug: Saline Nasal Spray
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by ORA, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Headaches [ Time Frame: Evaluated by the subject pre-ABC exposure, every 30 minutes during all ragweed exposures in the ABC, and post-ABC exposure ] [ Designated as safety issue: No ]

Enrollment: 0
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01076439

Sponsors and Collaborators
ORA, Inc.
Investigators
Principal Investigator: H. J. Crampton, MD ORA, Inc.
  More Information

No publications provided

Responsible Party: ORA, Inc.
ClinicalTrials.gov Identifier: NCT01076439     History of Changes
Other Study ID Numbers: 10-270-0006
Study First Received: February 24, 2010
Last Updated: February 21, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Fluticasone
Olopatadine
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014