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| ID | Type | Description | Link |
|---|---|---|---|
| IRB #14757A |
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Study stopped early due to slow accrual.
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| Name | Class |
|---|---|
| Schering-Plough | INDUSTRY |
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People with allergies frequently complain of a loss or reduction in the sense of smell.
In this study, the investigators propose to perform a randomized, double blind, placebo controlled parallel study of subjects with nasal allergies and decreased smell to determine the effect of a treatment for allergies on the sense of smell.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mometasone | Active Comparator | Mometasone intranasal steroid therapy daily for 2 weeks |
|
| Placebo | Placebo Comparator | 2 puffs of placebo spray in each nostril once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone | Drug | 2 puffs in each nostril once daily of nasal spray |
|
| Measure | Description | Time Frame |
|---|---|---|
| Histological Findings | Number of eosinophils per high-powered field (HPF) in olfactory biopsy taken after 2 weeks of study treatment (higher values indicate greater inflammation); average of three HPF reported | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Nasal Symptom Score at 2 Weeks | A decrease in scores between visits signifies an improvement in nasal symptoms. The total nasal symptom score can range from 0 to 27. | baseline and 2 weeks |
| Change From Baseline in Nasal Peak Inspiratory Flow at 2 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jayant M Pinto, 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 |
|---|---|---|---|
| 20819468 | Derived | Sivam A, Jeswani S, Reder L, Wang J, DeTineo M, Taxy J, Baroody FM, Naclerio RM, Pinto JM. Olfactory cleft inflammation is present in seasonal allergic rhinitis and is reduced with intranasal steroids. Am J Rhinol Allergy. 2010 Jul-Aug;24(4):286-90. doi: 10.2500/ajra.2010.24.3478. |
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Subjects were enrolled during relevant allergy seasons in Chicago, IL, from 2006 to 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mometasone | Active intranasal steroid therapy daily for 2 weeks |
| FG001 | Placebo | 2 puffs of placebo spray once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mometasone | Active intranasal steroid therapy daily for 2 weeks |
| BG001 | Placebo | 2 puffs of placebo spray 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 | Histological Findings | Number of eosinophils per high-powered field (HPF) in olfactory biopsy taken after 2 weeks of study treatment (higher values indicate greater inflammation); average of three HPF reported | Posted | Median | Full Range | eosinophils per HPF | 2 weeks |
|
|
During the two weeks 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 | Mometasone | Active intranasal steroid therapy daily for 2 weeks |
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Early termination due to slow accrual
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jayant Pinto, MD | 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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| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Placebo | Drug | 2 puffs in each nostril once daily of nasal spray |
|
An increase between visits indicates improved nasal airflow. |
| baseline and 2 weeks |
| Change From Baseline in Percentage of Eosinophils at 2 Weeks | A decrease between visits signifies a reduction in inflammation. Calculated from cytology specimens obtained by lavage. | baseline and 2 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Allergen sensitivity | Number | participants |
|
| Participants |
|
|
|
| Secondary | Change From Baseline in Total Nasal Symptom Score at 2 Weeks | A decrease in scores between visits signifies an improvement in nasal symptoms. The total nasal symptom score can range from 0 to 27. | Posted | Median | Full Range | units on a scale | baseline and 2 weeks |
|
|
|
|
| Secondary | Change From Baseline in Nasal Peak Inspiratory Flow at 2 Weeks | An increase between visits indicates improved nasal airflow. | Posted | Median | Full Range | liters per minute | baseline and 2 weeks |
|
|
|
|
| Secondary | Change From Baseline in Percentage of Eosinophils at 2 Weeks | A decrease between visits signifies a reduction in inflammation. Calculated from cytology specimens obtained by lavage. | Posted | Median | Full Range | percentage of eosinophils | baseline and 2 weeks |
|
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Placebo | 2 puffs of placebo spray once daily | 0 | 9 | 0 | 9 |
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| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |