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| Name | Class |
|---|---|
| Asphelia Pharmaceuticals | INDUSTRY |
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The purpose of this study is to see whether ASP-1001 when given as a nasal spray is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever) following nasal challenge with antigen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Topical ASP-1001 |
|
| 2 | Placebo Comparator | Placebo for Topical ASP-1001 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP-1001 nasal spray | Drug | 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sneezing Symptom | Sneezes. The change is calculated by adding the number of sneezes following both antigen challenges minus twice the number of sneezes after the diluent challenge. | 10 minutes after diluent challenge and 10 minutes after each antigen challenge |
| Change in Runny Nose Symptom | The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of runny nose following both antigen challenges minus twice the score of runny nose after the diluent challenge. | 10 minutes after diluent challenge and 10 minutes after each antigen challenge |
| Change in Stuffy Nose Symptom | The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of stuffy nose following both antigen challenges minus twice the score of stuffy nose after the diluent challenge. | 10 minutes after diluent challenge and 10 minutes after each antigen challenge |
| Change in Itching Symptom | The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of itchy nose following both antigen challenges minus twice the score of itchy nose after the diluent challenge. | 10 minutes after diluent challenge and 10 minutes after each antigen challenge |
| Measure | Description | Time Frame |
|---|---|---|
| Nasal Peak Inspiratory Flow Measurements | The value of nasal peak inspiratory flow. The change is calculated by adding the values of nasal peak inspiratory flow following both antigen challenges minus twice the value of nasal peak inspiratory flow after the diluent challenge. | 15 minutes after diluent challenge and 15 minutes after each antigen challenge |
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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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Topical ASP-1001 | Topical ASP-1001 ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge. |
| FG001 | Placebo for Topical ASP-1001 | Placebo for Topical ASP-1001 Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Washout Period of 2 Weeks |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants |
| 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 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 Sneezing Symptom | Sneezes. The change is calculated by adding the number of sneezes following both antigen challenges minus twice the number of sneezes after the diluent challenge. | Posted | Median | Inter-Quartile Range | sneezes | 10 minutes after diluent challenge and 10 minutes after each antigen challenge |
|
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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 | Topical ASP-1001 | Topical ASP-1001 ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Naclerio, MD | 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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| Placebo for ASP-1001 | Drug | 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge. |
|
| Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment | 15 minutes prior to treatment and 15 minutes post antigen challenges |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | Nasal Peak Inspiratory Flow Measurements | The value of nasal peak inspiratory flow. The change is calculated by adding the values of nasal peak inspiratory flow following both antigen challenges minus twice the value of nasal peak inspiratory flow after the diluent challenge. | Posted | Median | Inter-Quartile Range | L/min | 15 minutes after diluent challenge and 15 minutes after each antigen challenge |
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| Primary | Change in Runny Nose Symptom | The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of runny nose following both antigen challenges minus twice the score of runny nose after the diluent challenge. | Posted | Median | Inter-Quartile Range | units on a scale | 10 minutes after diluent challenge and 10 minutes after each antigen challenge |
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|
|
| Primary | Change in Stuffy Nose Symptom | The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of stuffy nose following both antigen challenges minus twice the score of stuffy nose after the diluent challenge. | Posted | Median | Inter-Quartile Range | units on a scale | 10 minutes after diluent challenge and 10 minutes after each antigen challenge |
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|
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| Primary | Change in Itching Symptom | The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of itchy nose following both antigen challenges minus twice the score of itchy nose after the diluent challenge. | Posted | Median | Inter-Quartile Range | units on a scale | 10 minutes after diluent challenge and 10 minutes after each antigen challenge |
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| Secondary | Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment | Posted | Median | Inter-Quartile Range | L/min | 15 minutes prior to treatment and 15 minutes post antigen challenges |
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| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Placebo for Topical ASP-1001 | Placebo for Topical ASP-1001 Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge. | 0 | 20 | 0 | 20 |
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| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |