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Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

NCT ID: NCT01058317

Last Updated: 2013-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-09-30

Brief Summary

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Juvenile onset recurrent respiratory papillomatosis (JORRP) is a rare, difficult to treat, benign tumor of the pediatric airway. Current therapy is mainly surgical, but in a significant portion of patients adjuvant therapy is required to control the disease process. Although multiple adjuvant medical therapies have been tried, success has been limited. We have seen some success in a limited amount of patients using orally administered propranolol. Our goal is to enroll a larger cohort of patients to determine the effectiveness of propranolol as an adjuvant therapy for JORRP.

Detailed Description

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Conditions

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Recurrent Respiratory Papillomatosis

Keywords

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respiratory, papilloma, pediatric, juvenile

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Children treated with propranolol

Group Type EXPERIMENTAL

Propranolol

Intervention Type DRUG

Propranolol 2mg/kg divided twice daily

Interventions

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Propranolol

Propranolol 2mg/kg divided twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1\. Biopsy proven with appropriate Human Papilloma Virus typing Recurrent Respiratory Papilloma
* 2\. Child under age 10
* 3\. Informed consent and where appropriate informed assent
* 4\. Children who have undergone at least 4 documented surgical interventions in the past year.

Exclusion Criteria

* Parental or child refusal to participate
* Heart failure
* Atrio-ventricular heart block
* Cardiac anomalies
* Low resting heart rate
* Low resting blood pressure
* Wolff-Parkinson White Syndrome
* Unexplained syncope
* Asthma or Reactive airway disease
* Renal or liver failure
* Expected long fasting periods, \>12 hours
* Diabetes Mellitus
* Hypersensitivity to propranolol
Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher Hartnick, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Eye and Ear Infirmary

Other Identifiers

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09-10-104

Identifier Type: -

Identifier Source: org_study_id