Trial Outcomes & Findings for Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide (NCT NCT03362515)

Last Updated: 2023-08-30

Results Overview

Nasal and paranasal polyposis based on endoscopic grading through Lund Kennedy score to measure the rate and degree of recurrence.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

6 months

Results posted on

2023-08-30

Participant Flow

Participant milestones

Participant milestones
Measure	Furosemide Furosemide: furosemide	Placebo Placebo: placebo
Overall Study STARTED	9	9
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Furosemide n=9 Participants Furosemide: furosemide	Placebo n=9 Participants Placebo: placebo	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 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.

Nasal and paranasal polyposis based on endoscopic grading through Lund Kennedy score to measure the rate and degree of recurrence.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Nasal and paranasal polyposis based on endoscopic grading through Meltzer score to measure the rate and degree of recurrence.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Nasal and paranasal polyposis based Sino-Nasal Outcome Test (SNOT-22) scores to measure impact on symptoms.

Outcome measures

Outcome data not reported

Adverse Events

Furosemide

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Furosemide n=9 participants at risk Furosemide: furosemide	Placebo n=9 participants at risk Placebo: placebo
Respiratory, thoracic and mediastinal disorders upper respiratory infection	11.1% 1/9 • Number of events 1 • 6 months	11.1% 1/9 • Number of events 1 • 6 months
General disorders increased headaches	0.00% 0/9 • 6 months	11.1% 1/9 • Number of events 1 • 6 months
Respiratory, thoracic and mediastinal disorders burning sensation in throat	0.00% 0/9 • 6 months	11.1% 1/9 • Number of events 1 • 6 months

Additional Information

Dr. Mindy Rabinowitz

Thomas Jefferson University

Phone: 215-955-6784

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place