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Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olopatadine HCL Nasal Spray, 0.6% | Experimental | Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily |
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| Fluticasone Propionate Nasal Spray, 50 mcg | Active Comparator | Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olopatadine HCL Nasal Spray, 0.6% | Drug | Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent 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 Percent Change in Instantaneous Total Nasal Symptom Score (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 Percent 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 Percent 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:
Exclusion:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sacramento, CA | Sacramento | California | 95819 | United States |
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Study recruitment occurred from May 14, 2008 - July 31, 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Olopatadine HCL Nasal Spray, 0.6% | Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily |
| FG001 | Fluticasone Propionate Nasal Spray, 50 Mcg | Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Fluticasone Propionate Nasal Spray, 50 mcg | Drug | Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily |
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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% 2 sprays per nostril twice daily |
| BG001 | Fluticasone Propionate Nasal Spray, 50 Mcg | Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily |
| 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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| Gender | Gender information was not collected for 3 patients at baseline. | Number | 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 Percent 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. | Posted | Mean | Standard Deviation | Percent change | 14 Days minus baseline |
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| Primary | Mean Percent Change in Instantaneous Total Nasal Symptom Score (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. | Posted | Mean | Standard Deviation | Percent change | 14 days minus baseline |
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| Primary | Mean Percent 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. | Posted | Mean | Standard Deviation | Percent change | 14 Days minus baseline |
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| Primary | Mean Percent 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. | Posted | Mean | Standard Deviation | Percent change | 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% 2 sprays per nostril twice daily | 0 | 65 | 0 | 65 | ||
| EG001 | Fluticasone Propionate Nasal Spray, 50 Mcg | Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily | 0 | 65 | 0 | 65 |
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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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