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To compare patient perceptions of the sensory attributes, including taste and aftertaste, of Olopatadine relative to azelastine when administered as a single dose in patients with allergic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Olopatadine 0.6% / Azelastine 137 mcg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olopatadine 0.6% / Azelastine 137 mcg | Drug | single dose; 2 sprays per nostril |
|
| Measure | Description | Time Frame |
|---|---|---|
| Product Preference Questionnaire for Immediate Taste | Using a set of coded responses, subjects evaluated product preference in regards to immediate taste | 5 min post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Taste and Aftertaste of Medication | 5 min, 45 min. |
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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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October 2008- November 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Olopatadine 0.6% / Azelastine 137 Mcg | Olopatadine 0.6% / Azelastine 137 mcg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Olopatadine 0.6% / Azelastine 137 Mcg | Olopatadine 0.6% / Azelastine 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 | Product Preference Questionnaire for Immediate Taste | Using a set of coded responses, subjects evaluated product preference in regards to immediate taste | Posted | Number | Percentage of participants | 5 min post-dose |
|
|
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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% / Azelastine 137 Mcg | Olopatadine 0.6% / Azelastine 137 mcg |
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Small sample size. The severity of symptoms experienced by patients may have masked their ability to detect taste and smell.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alcon Clinical | Alcon Research, Ltd. | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000069605 | Olopatadine Hydrochloride |
| C020976 | azelastine |
| ID | Term |
|---|---|
| D003990 | Dibenzoxepins |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Taste and Aftertaste of Medication | Not Posted | 5 min, 45 min. |
| 0 |
| 102 |
| 0 |
| 102 |
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| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |