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

Ora, Inc.

Status and phase

Withdrawn

Phase 4

Conditions

Allergic Rhinitis

Treatments

Drug: Fluticasone Furoate Nasal Spray

Drug: Saline Nasal Spray

Drug: Olopatadine Nasal Spray

Study type

Interventional

Funder types

Industry

Identifiers

NCT01076439

10-270-0006

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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