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A study to demonstrate the superiority of test article nasal spray relative to vehicle nasal spray for the treatment of seasonal allergic rhinitis for a 2 week period in patients aged 6 to 11 years with a history of seasonal allergic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olopatadine 0.6% 1 Spray | Experimental | Olopatadine HCl 0.6% 1 spray per nostril twice daily |
|
| Vehicle 1 spray | Placebo Comparator | Vehicle 1 spray per nostril twice daily |
|
| Olopatadine 0.6% 2 sprays | Experimental | Olopatadine HCl 0.6% 2 sprays per nostril twice daily |
|
| Vehicle 2 sprays | Placebo Comparator | Vehicle 2 sprays per nostril twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olopatadine Hydrochloride Nasal Spray 0.6% | Drug | Olopatadine HCl 1 or 2 sprays per nostril twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS) | Total Nasal Symptom Score comprised of scoring each of the following symptoms: runny nose, stuffy nose, itchy nose, and sneezing. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 4 individual symptom scores were then added together for a total nasal symptom score. The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 4 individual scores averaged across all days. | Baseline through 2 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS) | Total Ocular Symptom Score comprised of scoring each of the following symptoms: itchy eyes and watery eyes. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 2 individual symptom scores were then added together for a total ocular symptom score. The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 2 individual scores averaged across all days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ed Tumaian | ed.tumaian@alconlabs.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenilworth/IL | Kenilworth | Illinois | 60043 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21477426 | Derived | Meltzer EO, Blaiss M, Fairchild CJ. Comprehensive report of olopatadine 0.6% nasal spray as treatment for children with seasonal allergic rhinitis. Allergy Asthma Proc. 2011 May-Jun;32(3):213-20. doi: 10.2500/aap.2011.32.3448. Epub 2011 Apr 8. |
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Subjects completed a 4-16 day run-in period on vehicle prior to randomization.
The first subject was enrolled in the study on September 8, 2007 and the last subject exited the study on November 24, 2008. The study was conducted at medical clinics throughout the USA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Olopatadine 0.6% 1 Spray | Olopatadine HCl 0.6% 1 spray per nostril twice daily |
| FG001 | Vehicle 1 Spray | Vehicle 1 spray per nostril twice daily |
| FG002 | Olopatadine 0.6% 2 Sprays | Olopatadine HCl 0.6% 2 Sprays per nostril twice daily |
| FG003 | Vehicle 2 Sprays | Vehicle 2 sprays per nostril twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vehicle Run-In Period |
| |||||||||||||
| Randomized Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Olopatadine 0.6% 1 Spray | Olopatadine HCl 0.6% 1 spray per nostril twice daily |
| BG001 | Vehicle 1 Spray | Vehicle 1 spray per nostril twice daily |
| 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 | Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS) | Total Nasal Symptom Score comprised of scoring each of the following symptoms: runny nose, stuffy nose, itchy nose, and sneezing. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 4 individual symptom scores were then added together for a total nasal symptom score. The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 4 individual scores averaged across all days. | Posted | Least Squares Mean | Standard Error | Percent change of TNSS from baseline | Baseline through 2 weeks after randomization |
|
Up to 3 weeks
Adverse events were collected from the time of first dose with vehicle run-in until study exit. Adverse events were both volunteered and solicited
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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 0.6% 1 Spray | Olopatadine HCl 0.6% 1 spray per nostril twice daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope vasovagal | Nervous system disorders | MedDRA version 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alcon Clinical | Alcon Research, Ltd. | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D065631 | Rhinitis, Allergic |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| Vehicle | Drug | Vehicle 1 or 2 sprays per nostril twice daily |
|
| Baseline through 2 weeks after randomization |
| COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Olopatadine 0.6% 2 Sprays | Olopatadine HCl 0.6% 2 Sprays per nostril twice daily |
| BG003 | Vehicle 2 Sprays | Vehicle 2 sprays per nostril twice daily |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Vehicle 1 spray per nostril twice daily |
| OG002 | Olopatadine 0.6% 2 Sprays | Olopatadine HCl 0.6% 2 Sprays per nostril twice daily |
| OG003 | Vehicle 2 Sprays | Vehicle 2 sprays per nostril twice daily |
|
|
| Secondary | Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS) | Total Ocular Symptom Score comprised of scoring each of the following symptoms: itchy eyes and watery eyes. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 2 individual symptom scores were then added together for a total ocular symptom score. The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 2 individual scores averaged across all days. | Posted | Least Squares Mean | Standard Error | Percent change of TOSS from baseline | Baseline through 2 weeks after randomization |
|
|
|
| 0 |
| 298 |
| 29 |
| 298 |
| EG001 | Vehicle 1 Spray | Vehicle 1 spray per nostril twice daily | 0 | 297 | 21 | 297 |
| EG002 | Olopatadine 0.6% 2 Sprays | Olopatadine HCl 0.6% 2 Sprays per nostril twice daily | 0 | 296 | 26 | 296 |
| EG003 | Vehicle 2 Sprays | Vehicle 2 sprays per nostril twice daily | 0 | 297 | 30 | 297 |
| EG004 | Vehicle Run-in Period | Vehicle Run-in Period | 1 | 2,388 | 107 | 2,388 |
| Headache | Nervous system disorders | MedDRA version 10.0 | Systematic Assessment |
|
The sponsor reserves the right of review 60 days prior to any publication or presentation of information related to the study. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than study data and results. The Institution and the Primary Investigator agree not to publish any study related material other than above.
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |