Safety and Efficacy of Olopatadine 0.6% and Azelastine 137 Mcg in Vasomotor Rhinitis

Phase 4

Completed

• Conditions: Vasomotor Rhinitis
• Interventions: Drug: Olopatadine HCL (Patanase) Nasal Spray, 0.6%; Drug: Azelastine HCl (Astelin) Nasal Spray, 137 mcg

• Registration Number: NCT00979615
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to examine safety and efficacy of Patanase and Astelin in treating the symptoms of non-allergic vasomotor rhinitis (VMR).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-17
• Study First Submitted QC: 2009-09-17
• Study First Posted: 2009-09-18
• Primary Completion: 2009-11
• Status Verified: 2011-04
• Results First Submitted: 2011-04-14
• Results First Submitted QC: 2011-04-14
• Last Update Submitted: 2011-04-14
• Results First Posted: 2011-05-10
• Last Update Posted: 2011-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

• Diagnosis of VMR with at least 2 years of chronic non-allergic rhinitis
• Negative skin tests to a panel of allergens and positive histamine test within last 2 years
• History of symptoms related to defined VMR triggers

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Exclusion Criteria

• Nasal disorder, surgery, or concurrent disease that could interfere with evaluation of study medications
• Bacterial or viral infection within 14 days of first visit. Diagnosis of acute sinusitis within 30 days of first visit
• Chronic use of drugs that can cause rhinitis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Olopatadine HCL (Patanase) Nasal Spray, 0.6%	Olopatadine HCL Nasal Spray, 0.6%
2	Azelastine HCl (Astelin) Nasal Spray, 137 mcg	Azelastine HCl Nasal Spray, 137 mcg

Primary Outcome Measures

Name	Time	Method
Mean Change in 2-week rTNSS From Baseline	2 week	Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip 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 totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.

Secondary Outcome Measures

Name	Time	Method
Mean Change in Rhinorrhea Reflective Score	2 week	Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip 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 totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.
Mean Change Postnasal Drip Reflective Score	2 Weeks	Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip 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 totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.
Mean Change Nasal Congestion Reflective Score	2 Weeks	Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip 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 totaled for a composite score (TVSS 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 Sneezing Reflective Score	2 Weeks	Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip 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 totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.

Trial Locations

Locations (1)

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