Trial of Topical Verapamil in Chronic Rhinosinusitis With Nasal Polyps

Stopped early · Phase 1

Conditions studied: Sinusitis, Nasal Polyps

In brief

Verapamil is an L-type calcium channel blocker(CCB) which has been shown to reduce inflammation in a variety of tissues. Chronic rhinosinusitis with nasal polyps (CRSwNP) is characterized by eosinophilic inflammation as well as P-gp overexpression. A previous trial of oral Verapamil showed preliminary efficacy for the treatment of CRSwNP. The goal of this study is to evaluate the safety and efficacy of intranasal Verapamil in CRSwNP. The study was initially approved as a Phase Ib/II, but only the Phase Ib portion was completed as part of this protocol.

Key facts

Study ID

NCT03102190

Run by

Benjamin Bleier

People needed

6

Starts

2017-06-05

Expected to finish

2018-03-26

Last updated by the study team

2019-07-23

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients presenting to the Mass Eye and Ear Sinus Center
• Age 18-80 yrs old
• Diagnosed with Chronic Rhinosinusitis with Nasal Polyps according to the EPOS 2012 consensus criteria
• Post-operative with a Lund-Kennedy Poly score of <4
• Baseline SNOT-22 Score ≥ 30

You may not qualify if…

• Patients with the following comorbidities:
• GI Hypomotility
• Heart Failure
• Liver Failure
• Kidney Disease
• Muscular Dystrophy
• Pregnant or Nursing Females
• Steroid Dependency
• Hypertrophic Cardiomyopathy
• Any Atrial or Ventricular arrhythmia (ie. Atrial fibrillation, atrial flutter, etc..)
• Resting Heart Rate less than 60 beats per minute
• Baseline Systolic Blood Pressure less than 110 mmHg
• Baseline Diastolic Blood Pressure less than 70 mmHg
• Baseline Mean Arterial Pressure Less than 60 mmHg
• PR interval less than 0.12 seconds
• Patients taking the following medications:
• Aspirin
• Beta-blockers
• Cimetidine(Tagamet)
• Clarithromycin(Biaxin)
• Cyclosporin
• Digoxin
• Disopyramide(Norpace)
• Diuretics
• Erythromycin

Where it is running

• Massachusetts Eye and Ear — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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