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Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

Information source: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Recurrent Respiratory Papillomatosis

Intervention: Propranolol (Drug)

Phase: Phase 2/Phase 3

Status: Withdrawn

Sponsored by: Massachusetts Eye and Ear Infirmary

Official(s) and/or principal investigator(s):
Christopher Hartnick, MD, Principal Investigator, Affiliation: Massachusetts Eye and Ear Infirmary

Summary

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.

Clinical Details

Official title: Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Decreased number of surgeries

Secondary outcome: Improved voice quality

Eligibility

Minimum age: 1 Year. Maximum age: 10 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: January 2010
Last updated: November 19, 2013

Page last updated: August 23, 2015

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