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Poor recruitment
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The objectives of this protocol are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasaleze spray | Active Comparator | Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge |
|
| Placebo spray | Placebo Comparator | Placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasaleze Spray | Drug | Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Nasal Symptom Score After Nasal Challenge With Allergen Versus Diluent | Change in total nasal symptom score after nasal challenges (the change is calculated as the total nasal symptom score after allergen challenge - total nasal symptom score after diluent challenge) on the second of two days of nasal challenges following one week of pretreatment with Nasaleze or placebo. The nasal symptoms included number of sneezes, symptoms of runny and stuffy nose (separately for each nostril), and itchy nose/throat symptoms. Individual symptoms were score on a scale from 0-3 (0=no symptoms, 1=mild, 2=moderate, 3=severe). The maximum total nasal symptom score possible was 15 with higher scores indicating worse symptoms. | Day 2 after one week pretreatment with Nasaleze or placebo. |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert M Naclerio, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nasaleze Spray, Then Placebo Spray | This group first received Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge |
| FG001 | Placebo Spray, Then Nasaleze Spray | This group first received Placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen (grass or ragweed) challenge, followed by a 1 week washout and then received Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study Period 1 |
|
| ||||||||||||||||||
| Washout |
| |||||||||||||||||||
| Study Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nasaleze Spray, Then Placebo Spray | This group first received Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge |
| 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 Total Nasal Symptom Score After Nasal Challenge With Allergen Versus Diluent | Change in total nasal symptom score after nasal challenges (the change is calculated as the total nasal symptom score after allergen challenge - total nasal symptom score after diluent challenge) on the second of two days of nasal challenges following one week of pretreatment with Nasaleze or placebo. The nasal symptoms included number of sneezes, symptoms of runny and stuffy nose (separately for each nostril), and itchy nose/throat symptoms. Individual symptoms were score on a scale from 0-3 (0=no symptoms, 1=mild, 2=moderate, 3=severe). The maximum total nasal symptom score possible was 15 with higher scores indicating worse symptoms. | The analysis population includes the 12 participants who completed the study. | Posted | Median | Full Range | units on a scale | Day 2 after one week pretreatment with Nasaleze 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 | Nasaleze Spray | Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge Nasaleze Spray: Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo |
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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 |
|---|---|
| D000485 | Allergens |
| ID | Term |
|---|---|
| D000941 | Antigens |
| D001685 | Biological Factors |
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| Placebo spray | Other | Subjects are treated with placebo nasal spray then challenged with allergen |
|
| Allergen | Biological | Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 |
| Placebo Spray, Then Nasaleze Spray |
This group first received placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge Nasaleze Spray: Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo |
| OG001 | Placebo Spray | Placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge Placebo spray: Subjects are treated with placebo nasal spray then challenged with allergen Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Placebo Spray | Placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge Placebo spray: Subjects are treated with placebo nasal spray then challenged with allergen Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo | 0 | 14 | 0 | 14 |
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| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |