Phase 4 Completed N=150 Randomized Triple-blind Treatment

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

seasonal allergic rhinitis

Source: ClinicalTrials.gov NCT00845195 ↗

Enrolled (actual)

150

Serious AEs

0.0%

Results posted

Apr 2010

Primary outcomePrimary: Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline — 4.28; 4.15 Units on a scale

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline	4.28; 4.15	—
PRIMARY Mean Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline	4.22; 4.04	—
PRIMARY Mean Change in Instantaneous Total Nasal Symptom Scores (iTNSS) From Baseline	2.64; 2.49	—
PRIMARY Mean Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline	2.76; 2.54	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00845195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.