Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

Phase 2

Withdrawn

• Conditions: Recurrent Respiratory Papillomatosis
• Interventions: Drug: Propranolol

• Registration Number: NCT01058317
• Lead Sponsor: Massachusetts Eye and Ear Infirmary

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-27
• Study First Submitted QC: 2010-01-27
• Study First Posted: 2010-01-28
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2012-04
• Last Update Submitted: 2013-11-19
• Last Update Posted: 2013-11-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Children treated with propranolol	Propranolol	-

Primary Outcome Measures

Name	Time	Method
Decreased number of surgeries	3 months

Secondary Outcome Measures

Name	Time	Method
Improved voice quality	3 months