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

Phase 4

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: Olopatadine HCl Nasal Spray, 0.6%; Drug: Azelastine HCl Nasal Spray, 0.1%

• Registration Number: NCT00845195
• Lead Sponsor: Alcon Research

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-13
• Study First Submitted QC: 2009-02-13
• Study First Posted: 2009-02-18
• Study Start: 2009-03
• Primary Completion: 2009-05
• Results First Submitted: 2010-03-25
• Results First Submitted QC: 2010-03-25
• Status Verified: 2010-04
• Results First Posted: 2010-04-21
• Last Update Submitted: 2010-04-22
• Last Update Posted: 2010-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olopatadine HCl Nasal Spray, 0.6%	Olopatadine HCl Nasal Spray, 0.6%	-
Azelastine HCl Nasal Spray, 0.1%	Azelastine HCl Nasal Spray, 0.1%	-

Primary Outcome Measures

Name	Time	Method
Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline	14 days minus baseline	Responses to patient-completed diaries for reflective Total Nasal Symptom Scores (rTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12 . Reflective scores were assessed from the hour since the last dose of study medication.
Mean Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline	14 days minus baseline	Responses to patient-completed diaries for reflective Total Ocular Symptom Scores (rTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9 . Reflective scores were assessed from the hour since the last dose of study medication.
Mean Change in Instantaneous Total Nasal Symptom Scores (iTNSS) From Baseline	14 days minus baseline	Responses to patient-completed diaries for instantaneous Total Nasal Symptom Scores (iTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12 . Instantaneous scores were assessed at the time of daily dosing.
Mean Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline	14 days minus baseline	Responses to patient-completed diaries for instantaneous Total Ocular Symptom Scores (iTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9 . Instantaneous scores were assessed at the time of daily dosing.

Trial Locations

Locations (1)

Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States