Trial of Verapamil in Chronic Rhinosinusitis

Description

Verapamil is an L-type calcium channel blocker(CCB) which has been shown to reduce inflammation in a variety of tissues. Verapamil has also been shown to improve eosinophilic inflammation in an animal model of asthma and also functions as a P-glycoprotein(P-gp) inhibitor. A major subtype of chronic rhinosinusitis(CRS) is characterized by eosinophilic inflammation as well as P-gp overexpression. The goal of this study is to therefore see whether Verapamil may be used to treat CRS.

Study Start Date

May 2015

Estimated Completion Date

May 2019

Interventions

  • Drug: Verapamil HCl
  • Other: Placebo

Specialties

  • Allergy/Immunology: Cardiovascular/Pulm
  • Pharmacy: Drug Trials
  • Otolaryngology: Nose,Sinus
  • Physician Assistant: ENT

MeSH Terms

  • Anti-Arrhythmia Agents
  • Cardiovascular Agents
  • Nasal Polyps
  • Nose Diseases
  • Otorhinolaryngologic Diseases
  • Verapamil

Study ID

Massachusetts Eye and Ear Infirmary -- 15-009H

Status

Unknown

Trial ID

NCT02454608

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

158

Sponsor

Massachusetts Eye and Ear Infirmary

Inclusion Criteria

    1. Patients presenting to the MEEI Sinus Center 2. Age 18-80 yrs old 3. Diagnosed with Chronic Rhinosinusitis with Nasal Polyps according to the EPOS 2012 consensus criteria

Exclusion Criteria

    1. Patients with the following comorbidities:
  • GI Hypomotility
  • Heart Failure
  • Liver Failure
  • Kidney Disease
  • Muscular Dystrophy
  • Pregnant or Nursing Females
  • Steroid Dependency 2. 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 3. Patients with cardiac or conduction abnormality picked up by screening EKG

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Massachusetts Eye and Ear Infirmary - Boston, Massachusetts 2.8 miles Marcel M Miyake MD 617-794-3627 Marcel_Miyake@MEEI.harvard.edu

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