Comparison of Seasonal Allergic Rhinitis Treatment With 2 Antihistamines Used in Combination With Intranasal Corticosteroid

Condition(s) targeted: Seasonal Allergic Rhinitis

Intervention: Olopatadine HCl Nasal Spray, 0.6% (Drug); Azelastine HCl Nasal Spray, 0.1% (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Alcon Research

The purpose of this study is to compare the efficacy of Olopatadine Nasal Spray with Azelastine Nasal Spray when treatments are utilized in conjunction with Fluticasone Nasal Spray for the treatment of seasonal allergic rhinitis.

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

Primary outcome:

Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline

Mean Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline

Mean Change in Instantaneous Total Nasal Symptom Scores (iTNSS) From Baseline

Mean Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Able to provide consent/assent

- History of spring/summer allergic rhinitis

- Positive skin prick and/or intradermal test

- Absence of significant anatomic abnormalities, infection, bleeding, and mucosal

ulcerations

- Non-pregnant (where applicable)

- Able to complete daily diary

Exclusion Criteria:

- Smoker

- Concurrent disease such as rhinitis medicamentosa or large obstructive nasal polyps

- History of current chronic sinusitis

- Asthma

- Use of anti-allergy immunotherapy, corticosteroids, chronic use of long acting

antihistamines

- History of severe, unstable, or uncontrolled cardiovascular, hepatic, renal and/or

other diseases/illnesses

- History or evidence of nasolacrimal drainage system malfunction

Alcon Call Center for Trial Locations, Fort Worth, Texas 76134, United States

Starting date: March 2009
Last updated: April 22, 2010