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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Olopatadine HCL Nasal Spray, 0.6% |
|
| 2 | Active Comparator | Azelastine HCl Nasal Spray, 137 mcg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olopatadine HCL (Patanase) Nasal Spray, 0.6% | Drug | 2 sprays/ nostril BID |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center For Trial Locations | Fort Worth | Texas | 76134 | United States |
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September 9, 2009 - November 13, 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | Olopatadine HCL | Olopatadine HCL Nasal Spray, 0.6% |
| FG001 | Azelastine HCl | Azelastine HCl Nasal Spray, 137 mcg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Olopatadine HCL | Olopatadine HCL Nasal Spray, 0.6% |
| BG001 | Azelastine HCl | Azelastine HCl Nasal Spray, 137 mcg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Units on a scale | 2 week |
|
Two weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Olopatadine HCL | Olopatadine HCL Nasal Spray, 0.6% |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Taste Disturbance | Gastrointestinal disorders | MedDRA LLT | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria J. Tort, PhD | Alcon Research, Ltd. | (817) 302-5968 | Maria.Tort@alconlabs.com |
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| ID | Term |
|---|---|
| D012223 | Rhinitis, Vasomotor |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000069605 | Olopatadine Hydrochloride |
| D059085 | Nasal Sprays |
| C020976 | azelastine |
| ID | Term |
|---|---|
| D003990 | Dibenzoxepins |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Azelastine HCl (Astelin) Nasal Spray, 137 mcg |
| Drug |
2 sprays/ nostril BID |
|
| 2 week |
| 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. | 2 Weeks |
| 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. | 2 Weeks |
| 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. | 2 Weeks |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Azelastine HCl Nasal Spray, 137 mcg
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a scale | 2 week |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a scale | 2 Weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a scale | 2 Weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a scale | 2 Weeks |
|
|
|
| 0 |
| 63 |
| 5 |
| 63 |
| EG001 | Azelastine HCl | Azelastine HCl Nasal Spray, 137 mcg | 0 | 66 | 9 | 66 |
| Nose Bleeds | Respiratory, thoracic and mediastinal disorders | MedDRA LLT | Systematic Assessment |
|
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| D000336 | Aerosols |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |