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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of this study is to help us to a better understanding of how nose and eye symptoms are related in patients with allergies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Veramyst, then Placebo | Active Comparator | fluticasone furoate (Veramyst) nasal spray once daily for a week, then one week washout period followed by placebo nasal spray once daily for a week |
|
| Placebo, then Veramyst | Active Comparator | placebo nasal spray once daily for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily for a week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluticasone furoate | Drug | 2 puffs in each nostril once daily for 1 week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tryptase Level From Baseline to Post-antigen Challenge | Tryptase levels (mcg/L) were measured from nasal lavages | After one week of treatment wtih veramyst or placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Total Eye Symptom Scores After Antigen Challenge | Watery and itchy eye symptoms will be scored based on the following scale: 0=no symptoms, 1= mild, 2= moderate, 3= severe | After one week of treatment wtih veramyst or placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Naclerio, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
15 of the 24 subjects screened were eligible for the study and were randomly assigned to groups
24 subjects were screened for eligibility
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| ID | Title | Description |
|---|---|---|
| FG000 | Veramyst, Then Placebo | fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week, then one week washout period followed by placebo nasal spray once daily , 2 puffs/nostril, for a week |
| FG001 | Placebo, Then Veramyst | placebo nasal spray once daily (2 puffs/nostril) for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily (2 puffs/nostril) for a week |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Week) |
| |||||||||||||
| Washout (1 Week) |
| |||||||||||||
| Second Intervention (1 Week) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Veramyst, Then Placbeo | fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week, then one week washout period followed by placebo nasal spray once daily , 2 puffs/nostril, for a week |
| BG001 | Placebo, Then Veramyst |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Tryptase Level From Baseline to Post-antigen Challenge | Tryptase levels (mcg/L) were measured from nasal lavages | Posted | Median | Inter-Quartile Range | mcg/L | After one week of treatment wtih veramyst or placebo |
|
|
4 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 | Veramyst | fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Naclerio | University of Chicago | (773) 702-0080 | rnacleri@surgery.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| C523187 | fluticasone furoate |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Placebo | Drug | 2 puffs in each nostril once daily for 1 week |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
placebo nasal spray once daily (2 puffs/nostril) for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily (2 puffs/nostril) for a week |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| Secondary | Total Eye Symptom Scores After Antigen Challenge | Watery and itchy eye symptoms will be scored based on the following scale: 0=no symptoms, 1= mild, 2= moderate, 3= severe | Posted | Median | Inter-Quartile Range | units on a scale | After one week of treatment wtih veramyst or placebo |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Placebo | placebo nasal spray once daily (2 puffs/nostril) for a week | 0 | 15 | 0 | 15 |
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| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |