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Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

Primary Purpose

Recurrent Respiratory Papillomatosis

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Propranolol
Sponsored by
Massachusetts Eye and Ear Infirmary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Respiratory Papillomatosis focused on measuring respiratory, papilloma, pediatric, juvenile

Eligibility Criteria

1 Year - 10 Years (Child)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Children treated with propranolol

    Arm Description

    Outcomes

    Primary Outcome Measures

    Decreased number of surgeries

    Secondary Outcome Measures

    Improved voice quality

    Full Information

    First Posted
    January 27, 2010
    Last Updated
    November 19, 2013
    Sponsor
    Massachusetts Eye and Ear Infirmary
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01058317
    Brief Title
    Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis
    Official Title
    Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No participants enrolled
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    September 2010 (Actual)
    Study Completion Date
    September 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Massachusetts Eye and Ear Infirmary

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Recurrent Respiratory Papillomatosis
    Keywords
    respiratory, papilloma, pediatric, juvenile

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Children treated with propranolol
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Propranolol
    Intervention Description
    Propranolol 2mg/kg divided twice daily
    Primary Outcome Measure Information:
    Title
    Decreased number of surgeries
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Improved voice quality
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christopher Hartnick, MD
    Organizational Affiliation
    Massachusetts Eye and Ear Infirmary
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

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