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The study was terminated prematurely due to low enrollment numbers and the development of better drugs to treat polyps (ie. Biologics) which were not available when the study began.
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Prior studies have suggested that topical furosemide may reduce the recurrence of sinonasal polyposis following sinus surgery. This project aims to further investigate that claim through a blinded randomized controlled clinical trial following patients who undergo functional sinus surgery for chronic rhinosinusitis with sinonasal polyposis by randomly assigning participants to receive topical furosemide versus placebo nasal spray for 2 months post operatively. Outcomes would be compared at 6 months through endoscopic grading scores using Lund Kennedy and Meltzer scores as well as Sino-Nasal Outcome Test (SNOT-22) scores to measure the rate and degree of recurrence and impact on symptoms in the treatment group versus placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Furosemide | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide | Drug | furosemide |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Polyp Recurrence | Nasal and paranasal polyposis based on endoscopic grading through Lund Kennedy score to measure the rate and degree of recurrence. | 6 months |
| Polyp Recurrence | Nasal and paranasal polyposis based on endoscopic grading through Meltzer score to measure the rate and degree of recurrence. | 6 months |
| Polyp Recurrence | Nasal and paranasal polyposis based Sino-Nasal Outcome Test (SNOT-22) scores to measure impact on symptoms. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Department of Otolaryngology | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Furosemide | Furosemide: furosemide |
| FG001 | Placebo | Placebo: placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Furosemide | Furosemide: furosemide |
| BG001 | Placebo | Placebo: placebo |
| BG002 |
| 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 | Polyp Recurrence | Nasal and paranasal polyposis based on endoscopic grading through Lund Kennedy score to measure the rate and degree of recurrence. | This data was not collected and therefore no data analysis was done due to the study being terminated early secondary to 1) low enrollment due to the emergence of better medical alternatives to treat polyps (ie. Biologics) which made using furosemide not useful and 2) COVID. | Posted | 6 months |
|
6 months
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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 | Furosemide | Furosemide: furosemide | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mindy Rabinowitz | Thomas Jefferson University | 215-955-6784 | mindy.rabinowitz@jefferson.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 10, 2018 | Jun 7, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 20, 2020 | Jun 7, 2023 | ICF_001.pdf |
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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 |
|---|---|
| D005665 | Furosemide |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Drug |
placebo |
|
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Primary | Polyp Recurrence | Nasal and paranasal polyposis based on endoscopic grading through Meltzer score to measure the rate and degree of recurrence. | This data was not collected and therefore no data analysis was done due to the study being terminated early secondary to 1) low enrollment due to the emergence of better medical alternatives to treat polyps (ie. Biologics) which made using furosemide not useful and 2) COVID. | Posted | 6 months |
|
|
| Primary | Polyp Recurrence | Nasal and paranasal polyposis based Sino-Nasal Outcome Test (SNOT-22) scores to measure impact on symptoms. | This data was not collected and therefore no data analysis was done due to the study being terminated early secondary to 1) low enrollment due to the emergence of better medical alternatives to treat polyps (ie. Biologics) which made using furosemide not useful and 2) COVID. | Posted | 6 months |
|
|
| 9 |
| 0 |
| 9 |
| 1 |
| 9 |
| EG001 | Placebo | Placebo: placebo | 0 | 9 | 0 | 9 | 3 | 9 |
| increased headaches | General disorders | Non-systematic Assessment |
|
| burning sensation in throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |