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Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01058317
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : January 28, 2010
Last Update Posted : November 21, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Recurrent Respiratory Papillomatosis Drug: Propranolol Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis
Study Start Date : January 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Arm Intervention/treatment
Experimental: Children treated with propranolol Drug: Propranolol
Propranolol 2mg/kg divided twice daily

Primary Outcome Measures :
  1. Decreased number of surgeries [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Improved voice quality [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01058317

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

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Responsible Party: Massachusetts Eye and Ear Infirmary Identifier: NCT01058317     History of Changes
Other Study ID Numbers: 09-10-104
First Posted: January 28, 2010    Key Record Dates
Last Update Posted: November 21, 2013
Last Verified: April 2012
Keywords provided by Massachusetts Eye and Ear Infirmary:
respiratory, papilloma, pediatric, juvenile
Additional relevant MeSH terms:
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Respiratory Tract Infections
Papillomavirus Infections
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Diseases
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents