Trial Outcomes & Findings for Trial of Topical Verapamil in Chronic Rhinosinusitis With Nasal Polyps (NCT NCT03102190)

Last Updated: 2019-07-23

Results Overview

Dose Limiting Toxicity will be defined as a development of 2nd or 3rd degree heart block as measured by an EKG. (Phase Ib primary outcome)

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

6 participants

Primary outcome timeframe

1-8 weeks

Results posted on

2019-07-23

Participant milestones
Measure	Phase Ib Verapamil Hydrochloride Intranasal: Verapamil solution for injection, supplied in vials, will be utilized in a Neil Med Sinus Rinse of 240mL buffered normal saline.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Trial of Topical Verapamil in Chronic Rhinosinusitis With Nasal Polyps

Baseline characteristics by cohort
Measure	Phase Ib n=6 Participants Verapamil Hydrochloride Intranasal: Verapamil solution for injection, supplied in vials, will be utilized in a Neil Med Sinus Rinse of 240mL buffered normal saline.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants
Race (NIH/OMB) White	5 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	6 participants n=99 Participants

Timeframe: 1-8 weeks

Dose Limiting Toxicity will be defined as a development of 2nd or 3rd degree heart block as measured by an EKG. (Phase Ib primary outcome)

Outcome measures
Measure	Phase Ib n=6 Participants Verapamil Hydrochloride Intranasal: Verapamil solution for injection, supplied in vials, will be utilized in a Neil Med Sinus Rinse of 240mL buffered normal saline.
Number of Participants With Dose Limiting Toxicity	0 Participants

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Phase Ib n=6 participants at risk Verapamil Hydrochloride Intranasal: Verapamil solution for injection, supplied in vials, will be utilized in a Neil Med Sinus Rinse of 240mL buffered normal saline.
Cardiac disorders Low heart rate	16.7% 1/6 • Number of events 3 • 30 days
General disorders Headache	16.7% 1/6 • Number of events 1 • 30 days

Massachusetts Eye and Ear Infirmary

Phone: 617-573-6981