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| Name | Class |
|---|---|
| MedInvent, LLC | UNKNOWN |
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The purpose of this study is to see if a nasal steroid drug delivered to the nose with the NasoNeb™ inhaler improves the symptoms of people with perennial allergic rhinitis (year round allergy symptoms).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide | Active Comparator | Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily |
|
| Placebo | Placebo Comparator | Placebo delivered intranasally via NasoNeb nebulizer once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide | Drug | Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Nasal Peak Inspiratory Flow (NPIF) | NPIF was measured objectively in liters per minute with an In-Check Peak & Inspiratory Flow Meter (Ferraris Medical Inc, Orchard Park, NY). Subjects obtained 3 readings every morning and every evening and the greatest of the 3 measures were recorded. Total daily NPIF was calculated by adding the morning and evening values each day and the average of the change from baseline in NPIF for all days of was calculated | Baseline and 26 days |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24574125 | Derived | Brown K, Lane J, Silva MP, DeTineo M, Naclerio RM, Baroody FM. A pilot study of the effects of intranasal budesonide delivered by NasoNeb(R) on patients with perennial allergic rhinitis. Int Forum Allergy Rhinol. 2014 Jan;4(1):43-8. doi: 10.1002/alr.21239. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Budesonide | Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily |
| FG001 | Placebo | Placebo delivered intranasally via NasoNeb nebulizer once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Budesonide | Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily |
| BG001 | Placebo | Placebo delivered intranasally via NasoNeb nebulizer once daily |
| 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 Nasal Peak Inspiratory Flow (NPIF) | NPIF was measured objectively in liters per minute with an In-Check Peak & Inspiratory Flow Meter (Ferraris Medical Inc, Orchard Park, NY). Subjects obtained 3 readings every morning and every evening and the greatest of the 3 measures were recorded. Total daily NPIF was calculated by adding the morning and evening values each day and the average of the change from baseline in NPIF for all days of was calculated | Posted | Median | Standard Error | liters/min | Baseline and 26 days |
|
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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 | Budesonide | Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert M Naclerio | University of Chicago | 773-702-0080 | rnackeri@surgery.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Placebo | Drug | Placebo delivered intranasally via NasoNeb nebulizer once daily |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Placebo | Placebo delivered intranasally via NasoNeb nebulizer once daily | 0 | 20 | 0 | 20 |
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| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |