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The investigators hypothesize that treatment with QNASL will reduce nasal mucosal inflammation induced by the allergy season and prevent the changes in the microbiome caused by the allergy season.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QNASL nasal spray | Active Comparator | QNASL 320 mcg once-daily administered as two sprays in each nostril; 2 weeks of treatment |
|
| Placebo nasal spray | Placebo Comparator | Placebo nasal spray once-daily administered as two sprays in each nostril; 2 weeks of treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QNASL | Drug |
| ||
| Placebo nasal spray |
| Measure | Description | Time Frame |
|---|---|---|
| Total Nasal Symptom Score (TNSS) | The Total Nasal Symptom Score (TNSS) is the sum of scores for each of nasal congestion, sneezing, nasal itching, and rhinorrhea using a four point scale (0-3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the score for each of the symptoms to a total out of 12. TNSS was assessed daily and summed over 14 days; thus, the total score ranges from 0 to 168, with higher scores indicating a worse outcome. | Two weeks following initiation of treatment |
| Change in RQLQ Score From Baseline to Two Weeks | The Rhinoconjunctivitis Quality Of Life Questionnaire (RQLQ) is a self-administered disease-specific health-related quality of life instrument that measures the functional impairments that are most troublesome to adult patients as a result of their seasonal or perennial rhinoconjunctivitis of either allergic or non-allergic origin. There are 28 items each asking about symptoms during the previous week. Seven domains of activity limitation are included: activities (3 "patient-specific") limitation, sleep problems (3 items), nose symptoms (4 items), eye symptoms (4 items), non-nose/eye symptoms (7 items), practical problems (3 items) and emotional function (4 items)). Each item is reported using a 7-point scale (0 = not impaired at all, 6 = severely impaired), and a total score is calculated by averaging over all items (range 0-7). Higher scores reflect lower quality of life. | Two weeks following initiation of treatment |
| Change in Percent Eosinophils From Baseline to Two Weeks | The percentage of nasal eosinophils recovered from nasal lavage was assessed at baseline and after two weeks of treatment. | Two weeks following initiation of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jayant Pinto, 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 | QNASL Nasal Spray | QNASL 320 mcg once-daily administered as two sprays in each nostril; 2 weeks of treatment QNASL |
| FG001 | Placebo Nasal Spray | Placebo nasal spray once-daily administered as two sprays in each nostril; 2 weeks of treatment Placebo nasal spray |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | QNASL Nasal Spray | QNASL 320 mcg once-daily administered as two sprays in each nostril; 2 weeks of treatment QNASL |
| BG001 | Placebo Nasal Spray | Placebo nasal spray once-daily administered as two sprays in each nostril; 2 weeks of treatment Placebo nasal spray |
| 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 | Total Nasal Symptom Score (TNSS) | The Total Nasal Symptom Score (TNSS) is the sum of scores for each of nasal congestion, sneezing, nasal itching, and rhinorrhea using a four point scale (0-3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the score for each of the symptoms to a total out of 12. TNSS was assessed daily and summed over 14 days; thus, the total score ranges from 0 to 168, with higher scores indicating a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | Two weeks following initiation of treatment |
|
Two weeks following initiation of treatment
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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 | QNASL Nasal Spray | QNASL 320 mcg once-daily administered as two sprays in each nostril; 2 weeks of treatment QNASL |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jayant Pinto, PI | The University of Chicago | 773-702-6727 | jpinto@surgery.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo Nasal Spray | Placebo nasal spray once-daily administered as two sprays in each nostril; 2 weeks of treatment Placebo nasal spray |
|
|
|
| Primary | Change in RQLQ Score From Baseline to Two Weeks | The Rhinoconjunctivitis Quality Of Life Questionnaire (RQLQ) is a self-administered disease-specific health-related quality of life instrument that measures the functional impairments that are most troublesome to adult patients as a result of their seasonal or perennial rhinoconjunctivitis of either allergic or non-allergic origin. There are 28 items each asking about symptoms during the previous week. Seven domains of activity limitation are included: activities (3 "patient-specific") limitation, sleep problems (3 items), nose symptoms (4 items), eye symptoms (4 items), non-nose/eye symptoms (7 items), practical problems (3 items) and emotional function (4 items)). Each item is reported using a 7-point scale (0 = not impaired at all, 6 = severely impaired), and a total score is calculated by averaging over all items (range 0-7). Higher scores reflect lower quality of life. | Those analyzed included all participants with data for this measure at baseline and two weeks. | Posted | Mean | Standard Deviation | Change in scale score | Two weeks following initiation of treatment |
|
|
|
|
| Primary | Change in Percent Eosinophils From Baseline to Two Weeks | The percentage of nasal eosinophils recovered from nasal lavage was assessed at baseline and after two weeks of treatment. | Those analyzed included all participants with data for this measure at baseline and two weeks. | Posted | Mean | Standard Deviation | Change in percentage of eosinophils | Two weeks following initiation of treatment |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Placebo Nasal Spray | Placebo nasal spray once-daily administered as two sprays in each nostril; 2 weeks of treatment Placebo nasal spray | 0 | 19 | 0 | 19 | 0 | 19 |
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| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |