Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial

Alcon

Status and phase

Completed

Phase 4

Conditions

Seasonal Allergic Rhinitis

Treatments

Drug: Fluticasone Propionate Nasal Spray, 50 mcg

Drug: Olopatadine HCL Nasal Spray, 0.6%

Study type

Interventional

Funder types

Industry

Identifiers

SMA-08-06

Details and patient eligibility

About

Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis

Enrollment

130 patients

Sex

All

Ages

12+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

A history of spring/summer seasonal allergies.
Positive skin prick test for the currently prevalent allergen of the area.
Confirmed absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations on nasal examination prior to administration of test article.
For pre-menopausal females, a negative pregnancy test prior to entry into the study, and, if sexually active, agreement to use adequate birth control methods throughout the study.

Exclusion:

History of chronic sinusitis.
Asthma, with the exception of intermittent asthma.
Smokers.
Known non-responders to antihistamines.
Chronic or intermittent use of inhaled, oral, intramuscular, intravenous or dermal potent or super-potent topical corticosteroids.
Chronic use of long acting antihistamines.
Upper or lower respiratory infection within 14 days of Visit 1. Diagnosis of acute sinusitis within 30 days of Visit 1.
Relatives of study site staff or other individuals who had access to the clinical study protocol.
Participation in any other investigational study within 30 days before entry into this study or concomitantly with this study.