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Terminated based on mutual agreement between PI and sponsor (Glaxo Smith Kline)
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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Fluticasone furoate is being studied to determine whether treatment with a topical nasal steroid, in patients with existing nasal polyps , can not only improve symptoms but also suppress the recurrence of clinically significant nasal polyp obstruction and prevent surgical intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluticasone Furoate | Active Comparator | nasal steroid |
|
| Placebo | Placebo Comparator | nasal spray vehicle without drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluticasone furoate | Drug | nasal steroid spray |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate the Effect of Once Daily Nasal Steroid Therapy With Fluticasone Furoate Nasal Spray (110 mcg/Day) in Suppressing Nasal Polyp-induced Symptoms Over the Course of 16 Weeks in Patients Presenting to the Clinic With Active Nasal Polypoid Disease. | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate the Efficacy and Safety of Once Daily Nasal Steroid Therapy With Fluticasone Furoate Nasal Spray in Suppressing the Signs of Recurrence of Nasal Polyps Over the Course of 16 Weeks. | 18 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Are pregnant and/or breast-feeding.
History of alcohol or drug abuse in the past year.
Signs and symptoms suggestive of fulminant bacterial sinusitis (fever >101 F, persistent severe unilateral facial or tooth pain, facial swelling).
Allergies to nasal corticosteroids
.Other chronic significant medical illnesses 6) Maintenance oral prednisone therapy for other chronic medical conditions.
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-
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The PI has left the institution and neither he, nor the data if any, is available. All information provided has been obtained from the Johns Hopkins University School of Medicine Institutional Review Board and was only available as one arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | nasal steroid fluticasone furoate: nasal steroid spray OR nasal spray vehicle without drug placebo: nasal steroid vehicle without drug |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The PI has left the institution and neither he, nor the data if any, is available. All information provided has been obtained from the Johns Hopkins University School of Medicine Institutional Review Board and was only available as one arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | nasal steroid fluticasone furoate: nasal steroid spray OR nasal spray vehicle without drug placebo: nasal steroid vehicle without drug |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | To Evaluate the Effect of Once Daily Nasal Steroid Therapy With Fluticasone Furoate Nasal Spray (110 mcg/Day) in Suppressing Nasal Polyp-induced Symptoms Over the Course of 16 Weeks in Patients Presenting to the Clinic With Active Nasal Polypoid Disease. | The PI has left the institution and neither he, nor the data if any, is available. All information provided has been obtained from the Johns Hopkins University School of Medicine Institutional Review Board. | Posted | 18 weeks |
|
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No data was collected/is available for the study as it was terminated prematurely and the PI has since left the institution. The information in Adverse events is presenter per arm, as the arm assignment, if any, is unknown.
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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 | All Participants | nasal steroid fluticasone furoate: nasal steroid spray OR nasal spray vehicle without drug placebo: nasal steroid vehicle without drug |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johns Hopkins University Clinical Trials Program | Johns Hopkins University School of Medicine | 410-550-6484 | registerclinicaltrials@jhmi.edu |
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| ID | Term |
|---|---|
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
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| ID | Term |
|---|---|
| C523187 | fluticasone furoate |
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| Other |
nasal steroid vehicle without drug |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | To Evaluate the Efficacy and Safety of Once Daily Nasal Steroid Therapy With Fluticasone Furoate Nasal Spray in Suppressing the Signs of Recurrence of Nasal Polyps Over the Course of 16 Weeks. | No data was collected/is available for the study as it was terminated prematurely and the PI has since left the institution. | Posted | 18 weeks |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |