Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Alcon Research
Treatments:
Fluticasone
Olopatadine Hydrochloride
Xhance
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.