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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olopatadine HCl Nasal Spray, 0.6% | Experimental |
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| Azelastine HCl Nasal Spray, 0.1% | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olopatadine HCl Nasal Spray, 0.6% | Drug | 2 sprays/nostril, twice daily (in addition to Fluticasone Propionate Nasal Spray 50 mcg 2 sprays/nostril once daily) for 14 +/- 3 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From 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. | 14 days minus baseline |
| Mean Change in Reflective Total Ocular Symptom Scores (rTOSS) From 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. | 14 days minus baseline |
| Mean Change in Instantaneous Total Nasal Symptom Scores (iTNSS) From 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. | 14 days minus baseline |
| Mean Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
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March 8, 2009 - April 22, 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | Olopatadine HCl Nasal Spray, 0.6% | Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg |
| FG001 | Azelastine HCl Nasal Spray, 0.1% | Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Azelastine HCl Nasal Spray, 0.1% | Drug | 2 sprays/nostril, twice daily (in addition to Fluticasone Propionate Nasal Spray 50 mcg 2 sprays/nostril once daily) for 14 +/- 3 days |
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| 14 days minus baseline |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Olopatadine HCl Nasal Spray, 0.6% | Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg |
| BG001 | Azelastine HCl Nasal Spray, 0.1% | Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 Reflective Total Nasal Symptom Score (rTNSS) From 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. | The analysis was per protocol. 15 patients were not included in the analysis. | Posted | Mean | Standard Deviation | Units on a scale | 14 days minus baseline |
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| Primary | Mean Change in Reflective Total Ocular Symptom Scores (rTOSS) From 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. | The analysis was per protocol. 15 patients were not included in the analysis. | Posted | Mean | Standard Deviation | Units on a scale | 14 days minus baseline |
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| Primary | Mean Change in Instantaneous Total Nasal Symptom Scores (iTNSS) From 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. | The analysis was per protocol. 15 patients were not included in the analysis. | Posted | Mean | Standard Deviation | Units on a scale | 14 days minus baseline |
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| Primary | Mean Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From 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. | The analysis was per protocol. 15 patients were not included in the analysis. | Posted | Mean | Standard Deviation | Units on a scale | 14 days minus baseline |
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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 Nasal Spray, 0.6% | Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg | 0 | 75 | 0 | 75 | ||
| EG001 | Azelastine HCl Nasal Spray, 0.1% | Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg | 0 | 75 | 0 | 75 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alcon Clinical | Alcon Research Ltd. | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D012220 | Rhinitis |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| >=65 years |
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| Male |
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