A Phase 2 interventional study of Furosemide and Placebo in Nasal Polyps, sponsored by Thomas Jefferson University. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-08-30.
Sponsored by Thomas Jefferson University · Phase 2, Interventional, and Treatment
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.
236 studies on the registry are indexed under Nasal Polyps; 68 are open to participants now.
This study's enrollment of 18 is below the median of 60 across 181 interventional studies indexed under Nasal Polyps.
Browse Nasal Polyps studies →Thomas Jefferson University is the lead sponsor of 393 studies on the registry; 70 are open to participants now.
Of its 45 completed or terminated interventional studies of FDA-regulated products, 21 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Furosemide
Drug: Placebo
furosemide
placebo
Polyp Recurrence
Nasal and paranasal polyposis based on endoscopic grading through Lund Kennedy score to measure the rate and degree of recurrence.
Time frame: 6 months
Polyp Recurrence
Nasal and paranasal polyposis based on endoscopic grading through Meltzer score to measure the rate and degree of recurrence.
Time frame: 6 months
Polyp Recurrence
Nasal and paranasal polyposis based Sino-Nasal Outcome Test (SNOT-22) scores to measure impact on symptoms.
Time frame: 6 months
| Milestone | Furosemide | Placebo |
|---|---|---|
| Started | 9 | 9 |
| Completed | 6 | 6 |
| Not completed | 3 | 3 |
Nasal and paranasal polyposis based on endoscopic grading through Lund Kennedy score to measure the rate and degree of recurrence.
No measurements were reported for this outcome.
Nasal and paranasal polyposis based on endoscopic grading through Meltzer score to measure the rate and degree of recurrence.
No measurements were reported for this outcome.
Nasal and paranasal polyposis based Sino-Nasal Outcome Test (SNOT-22) scores to measure impact on symptoms.
No measurements were reported for this outcome.
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Furosemide | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) |
| Placebo | 0/9 (0%) | 0/9 (0%) | 3/9 (33.3%) |
| Event | Furosemide | Placebo |
|---|---|---|
| upper respiratory infectionRespiratory, thoracic and mediastinal disorders | 1/9 | 1/9 |
| increased headachesGeneral disorders | 0/9 | 1/9 |
| burning sensation in throatRespiratory, thoracic and mediastinal disorders | 0/9 | 1/9 |
| Age, Categorical(Participants) | Furosemide | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 9 | 9 | 18 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Furosemide | Placebo | Total |
|---|---|---|---|
| Female | 4 | 5 | 9 |
| Male | 5 | 4 | 9 |
| Race (NIH/OMB)(Participants) | Furosemide | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 3 | 6 |
| White | 6 | 6 | 12 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Furosemide | Placebo | Total |
|---|---|---|---|
| United States | 9 | 9 | 18 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Furosemide