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

Condition(s) targeted: Allergic Rhinitis

Intervention: Fluticasone Furoate Nasal Spray (Drug); Olopatadine Nasal Spray (Drug); Saline Nasal Spray (Drug)

Phase: Phase 4

Status: Withdrawn

Sponsored by: ORA, Inc.

Official(s) and/or principal investigator(s):
H. J. Crampton, MD, Principal Investigator, Affiliation: ORA, Inc.

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.

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)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Nasal Signs and Symptoms (TNSS)

Secondary outcome:

Peak Expiratory Flow Rate (PEFR)

Peak Nasal Inspiratory Flow (PNIF)

Headaches

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Last updated: February 21, 2012