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

Phase 4

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: Olopatadine HCL Nasal Spray, 0.6%; Drug: Fluticasone Propionate Nasal Spray, 50 mcg

• Registration Number: NCT00691665
• Lead Sponsor: Alcon Research

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-04
• Study First Posted: 2008-06-05
• Primary Completion: 2009-01
• Results First Submitted: 2010-01-26
• Results First Submitted QC: 2010-02-23
• Status Verified: 2010-03
• Results First Posted: 2010-03-10
• Last Update Submitted: 2010-03-23
• Last Update Posted: 2010-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

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%	Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
Fluticasone Propionate Nasal Spray, 50 mcg	Fluticasone Propionate Nasal Spray, 50 mcg	Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily

Primary Outcome Measures

Name	Time	Method
Mean Percent 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 Percent Change in Instantaneous Total Nasal Symptom Score (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 Percent 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 Percent 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)

Sacramento, CA; 🇺🇸 Sacramento, California, United States