Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

This study has been withdrawn prior to enrollment.
(No participants enrolled)
Sponsor:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT01058317
First received: January 27, 2010
Last updated: November 19, 2013
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Recurrent Respiratory Papillomatosis
Drug: Propranolol
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

Resource links provided by NLM:


Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:
  • Decreased number of surgeries [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improved voice quality [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Children treated with propranolol Drug: Propranolol
Propranolol 2mg/kg divided twice daily

  Eligibility

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058317

Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
Principal Investigator: Christopher Hartnick, MD Massachusetts Eye and Ear Infirmary
  More Information

No publications provided

Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01058317     History of Changes
Other Study ID Numbers: 09-10-104
Study First Received: January 27, 2010
Last Updated: November 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts Eye and Ear Infirmary:
respiratory, papilloma, pediatric, juvenile

Additional relevant MeSH terms:
Papilloma
Papillomavirus Infections
Respiratory Tract Infections
DNA Virus Infections
Infection
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Respiratory Tract Diseases
Tumor Virus Infections
Virus Diseases
Propranolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 23, 2014