An Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo

Ora, Inc.

Status and phase

Completed

Phase 4

Conditions

Allergic Conjunctivitis

Allergic Rhinitis

Treatments

Drug: Fluticasone Propionate Nasal Spray

Drug: Saline Nasal Spray

Study type

Interventional

Funder types

Industry

Identifiers

NCT01439815

11-100-0007

Details and patient eligibility

About

The purpose of this study is to evaluate the onset of action of fluticasone propionate nasal spray compared to placebo nasal spray in reducing nasal allergic signs and symptoms following ragweed exposure in the Allergen BioCube (ABC) after up to 14 days of at home dosing.

Enrollment

22 patients

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

known intolerance or allergy to antihistamines or corticosteroids;
have a compromised lung function at Visit 1;
develop a compromised lung function at Visits 2-6
have any presence of active sinus or nasal infection at any visit;
have experienced an acute upper or lower respiratory tract infection or acute sinusitis within 30 days of 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 a known history of glaucoma
have planned surgery (nasal, ocular or systemic) during the trial period or within 30 days thereafter;
inability or refusal to discontinue contact lens wear during all visits;
use disallowed medications during the study or appropriate pre-study washout period