Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

Recurrent Respiratory Papillomatosis Clinical Trial

Official title:

Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01058317
• Other study ID #: 09-10-104
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: January 27, 2010
• Last updated: November 19, 2013
• Start date: January 2010
• Est. completion date: September 2010

Study information

• Verified date: April 2012
• Source: Massachusetts Eye and Ear Infirmary
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 10 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Papilloma
• Papillomavirus Infections
• Recurrent Respiratory Papillomatosis
• Respiratory Tract Infections

Intervention

Drug:
• Propranolol
Propranolol 2mg/kg divided twice daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreased number of surgeries		3 months	No
Secondary	Improved voice quality		3 months	No