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| Name | Class |
|---|---|
| Schering-Plough | INDUSTRY |
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We hypothesize that those patients with purely seasonal allergic rhinitis will decongest better than those subjects with another cause contributing to their symptoms. These latter patients will not improve as well on an intranasal steroid as those who decongest well, potentially explaining the 60% response rate in prior studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 2 weeks of treatment |
|
| 2 | Placebo Comparator | 2 weeks of treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mometasone furoate nasal spray | Drug | 2 puffs in each nostril once a day for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global Assessment | Global Assessment: 3=significantly improved, 2=moderately improved, 1=mildly improved, 0=no change, -1=mildly worse, -2=moderately worse, and -3=significantly worse | at week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in RQLQ: Overall | The RQLQ is a disease-specific measure of a patient's quality of life. It includes domains that measure nasal and eye symptoms as well as those of activity, sleep, non-nasal/eye symptoms, practical and emotional measures. A scale of 0-6 is used to record the patient responses, with lower scores reflecting a better quality of life. The average score of each domain is calculated as well as an overall domain score reflecting the average of all scores. |
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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 |
|---|---|---|---|
| 21262099 | Derived | Sharma S, Vasnani R, De Tineo M, Du G, Pinto JM, Baroody FM, Naclerio RM. Recruitment factors which affect the outcome of a seasonal allergic rhinitis trial. Allergy Asthma Proc. 2011 Jan-Feb;32(1):55-63. doi: 10.2500/aap.2011.32.3414. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mometasone Furoate | 2 weeks of treatment mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks |
| FG001 | Placebo | 2 weeks of treatment placebo : 2 puffs in each nostril once a day for 2 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mometasone Furoate | 2 weeks of treatment mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks |
| BG001 | Placebo | 2 weeks of treatment placebo : 2 puffs in each nostril once a day for 2 weeks |
| 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 | Global Assessment | Global Assessment: 3=significantly improved, 2=moderately improved, 1=mildly improved, 0=no change, -1=mildly worse, -2=moderately worse, and -3=significantly worse | There were one patient in the Mometasone Furoate group and two patients in the Placebo group with missing values. | Posted | Mean | Standard Deviation | units on a scale | at week 2 |
|
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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 Furoate | 2 weeks of treatment mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks |
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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 |
|---|---|
| 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 a day for 2 weeks |
|
|
| Baseline and 2 weeks |
| Changes in RQLQ: Activity | The RQLQ activity range: 0-6. Higher scores indicate a worse quality of life. | Baseline and 2 weeks |
| Changes in RQLQ: Sleep | The RQLQ sleep range: 0-6. Higher scores indicate a worse quality of life. | Baseline and 2 weeks |
| Changes in RQLQ: Non-Nasal/Eye | The RQLQ non-nasal/eye range: 0-6. Higher scores indicate a worse quality of life. | Baseline and 2 weeks |
| Changes in RQLQ: Practical | The RQLQ practical range: 0-6. Higher scores indicate a worse quality of life. | Baseline and 2 weeks |
| Changes in RQLQ: Nasal | The RQLQ nasal range: 0-6. Higher scores indicate a worse quality of life. | Baseline and 2 weeks |
| Changes in RQLQ: Emotional | The RQLQ emotional range: 0-6. Higher scores indicate a worse quality of life. | Baseline and 2 weeks |
| Changes in RQLQ: Eye | The RQLQ eye range: 0-6. Higher scores indicate a worse quality of life. | Baseline and 2 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Secondary | Changes in RQLQ: Overall | The RQLQ is a disease-specific measure of a patient's quality of life. It includes domains that measure nasal and eye symptoms as well as those of activity, sleep, non-nasal/eye symptoms, practical and emotional measures. A scale of 0-6 is used to record the patient responses, with lower scores reflecting a better quality of life. The average score of each domain is calculated as well as an overall domain score reflecting the average of all scores. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 2 weeks |
|
|
|
|
| Secondary | Changes in RQLQ: Activity | The RQLQ activity range: 0-6. Higher scores indicate a worse quality of life. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 2 weeks |
|
|
|
|
| Secondary | Changes in RQLQ: Sleep | The RQLQ sleep range: 0-6. Higher scores indicate a worse quality of life. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 2 weeks |
|
|
|
|
| Secondary | Changes in RQLQ: Non-Nasal/Eye | The RQLQ non-nasal/eye range: 0-6. Higher scores indicate a worse quality of life. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 2 weeks |
|
|
|
|
| Secondary | Changes in RQLQ: Practical | The RQLQ practical range: 0-6. Higher scores indicate a worse quality of life. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 2 weeks |
|
|
|
|
| Secondary | Changes in RQLQ: Nasal | The RQLQ nasal range: 0-6. Higher scores indicate a worse quality of life. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 2 weeks |
|
|
|
|
| Secondary | Changes in RQLQ: Emotional | The RQLQ emotional range: 0-6. Higher scores indicate a worse quality of life. | There were one patient in the Mometasone Furoate group with a missing value. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 2 weeks |
|
|
|
|
| Secondary | Changes in RQLQ: Eye | The RQLQ eye range: 0-6. Higher scores indicate a worse quality of life. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 2 weeks |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Placebo | 2 weeks of treatment placebo : 2 puffs in each nostril once a day for 2 weeks | 0 | 20 | 0 | 20 |
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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 |