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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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Rationale and objectives:
Fluticasone furoate nasal spray (Veramyst) has been shown to improve ocular symptoms when used for the treatment of seasonal allergic rhinitis during the ragweed pollen season. Although this is the only published report of an intranasal corticosteroid shown to effectively treat ocular symptoms, the mechanism has not been delineated. Furthermore, the tears of patients with allergic conjunctivitis are known to have increased concentrations of cytokines and allergic mediators.
The objective of this study is to determine if the positive effects of Veramyst nasal spray on ocular symptoms is via the inhibition of allergic mediators in the eyes. The investigators will conduct a double blind placebo controlled trial to determine if Veramyst nasal spray decreases the amount of allergic mediators in the tears of subjects randomized to Veramyst nasal spray versus placebo. The investigators will also compare the subjects' symptoms to the amount of allergic mediators detected in their tears.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo nasal spray | Placebo Comparator |
| |
| Fluticasone furoate nasal spray | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone furoate nasal spray | Drug | 2 sprays each nostril every morning for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eosinophilic Cationic Protein (ECP) Levels | Tear samples from the participants eyes were collect and were to be used for measuring esinophilic cationic prtein, but this was not measured because the volume of tears were to low. | Samples taken at initial visit & 2 week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Histamine Content in the Tears Was Measured. | Tear samples were assayed for histamine by ELISA | Samples taken at initial visit & 2 week follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J. Moy, MD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
There was no run in period. All 20 participants that enrolled in this study were included in the trial.
Subjects were recruited during the spring pollen season of 2009 at a large urban medcial center's allergy clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluticasone Furoate Nasal Spray | Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks |
| FG001 | Placebo Nasal Spray | Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluticasone Furoate Nasal Spray | Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks |
| BG001 | Placebo Nasal Spray | Placebo nasal spray : 2 sprays each nostril every morning 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, 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 | Eosinophilic Cationic Protein (ECP) Levels | Tear samples from the participants eyes were collect and were to be used for measuring esinophilic cationic prtein, but this was not measured because the volume of tears were to low. | Tear samples from the participants eyes were collect and were to be used for measuring esinophilic cationic prtein, but this was not measured because the volume of tears were to low. | Posted | Samples taken at initial visit & 2 week follow-up |
|
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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 | Fluticasone Furoate Nasal Spray | Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James N. Moy, M.D. | Rush University Medical College | 312-942-6176 | jmoy@rush.edu |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Placebo nasal spray | Drug | 2 sprays each nostril every morning for 2 weeks |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Histamine Content in the Tears Was Measured. | Tear samples were assayed for histamine by ELISA | All participants had tears measured for histamine. | Posted | Mean | Standard Error | ng/ml | Samples taken at initial visit & 2 week follow-up |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 0 |
| EG001 | Placebo Nasal Spray | Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks | 0 | 10 | 0 | 0 |
The sponsor has the right to review the results prior to publication of the results. But no embargo or time limit was given.
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| >0.1 |
| Mean Difference (Final Values) |
| 2.0 |
| Standard Error of the Mean |
| 0.5 |
| 95 |
| Yes |
| Non-Inferiority or Equivalence |
t-test showed no different between the 2 groups. |