Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

Mass Eye and Ear

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Recurrent Respiratory Papillomatosis

Treatments: Drug: Propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT01058317

09-10-104

Details and patient eligibility

About

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.

Sex: All

Ages: 1 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Children treated with propranolol

Experimental group

Treatment:

Drug: Propranolol