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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This study has been withdrawn prior to enrollment.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: April 20, 2012
Last verified: April 2012
History of Changes
  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: Allocation: Non-Randomized
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:

U.S. FDA Resources

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
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: April 20, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 22, 2013