Trial of Topical Verapamil in Chronic Rhinosinusitis With Nasal Polyps

• Status: Terminated
• Trial end date: 2018-03-26
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Benjamin Bleier
• Treatments: Verapamil

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Flecainide

• HIV Protease Inhibitors(Indinavir, Nelfinavir, Ritonavir)

• Quinidine

• Lithium

• Pioglitazone

• Rifampin

• St Johns Wort

• Patients with cardiac or conduction abnormality picked up by screening EKG

• Post-op patients with surgery within 3 months prior to enrollment.