Back to resultsSafety and Efficacy of Olopatadine 0.6% and Azelastine 137 Mcg in Vasomotor Rhinitis
Primary Purpose
Vasomotor Rhinitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Olopatadine HCL (Patanase) Nasal Spray, 0.6%
Azelastine HCl (Astelin) Nasal Spray, 137 mcg
Sponsored by
About this trial
This is an interventional treatment trial for Vasomotor Rhinitis focused on measuring vasomotor rhinitis, chronic non-allergic rhinitis, VMR
Eligibility Criteria
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
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
Sites / Locations
- Contact Alcon Call Center For Trial Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Olopatadine HCL Nasal Spray, 0.6%
Azelastine HCl Nasal Spray, 137 mcg
Outcomes
Primary Outcome Measures
Mean Change in 2-week rTNSS From Baseline
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
Mean Change in Rhinorrhea Reflective Score
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00979615
Brief Title
Safety and Efficacy of Olopatadine 0.6% and Azelastine 137 Mcg in Vasomotor Rhinitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Alcon Research
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasomotor Rhinitis
Keywords
vasomotor rhinitis, chronic non-allergic rhinitis, VMR
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Olopatadine HCL Nasal Spray, 0.6%
Arm Title
2
Arm Type
Active Comparator
Arm Description
Azelastine HCl Nasal Spray, 137 mcg
Intervention Type
Drug
Intervention Name(s)
Olopatadine HCL (Patanase) Nasal Spray, 0.6%
Intervention Description
2 sprays/ nostril BID
Intervention Type
Drug
Intervention Name(s)
Azelastine HCl (Astelin) Nasal Spray, 137 mcg
Intervention Description
2 sprays/ nostril BID
Primary Outcome Measure Information:
Title
Mean Change in 2-week rTNSS From Baseline
Description
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.
Time Frame
2 week
Secondary Outcome Measure Information:
Title
Mean Change in Rhinorrhea Reflective Score
Description
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.
Time Frame
2 week
Title
Mean Change Postnasal Drip Reflective Score
Description
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.
Time Frame
2 Weeks
Title
Mean Change Nasal Congestion Reflective Score
Description
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.
Time Frame
2 Weeks
Title
Mean Change in Sneezing Reflective Score
Description
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.
Time Frame
2 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Facility Information:
Facility Name
Contact Alcon Call Center For Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
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Safety and Efficacy of Olopatadine 0.6% and Azelastine 137 Mcg in Vasomotor Rhinitis
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