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Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

NCT01058317 — Phase 2 / Phase 3, Withdrawn, Massachusetts Eye and Ear Infirmary
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RegistryNCT01058317
StatusWithdrawn - No participants enrolled
PhasePhase 2 / Phase 3
Study typeInterventional; na, single group, masking: none, treatment
SponsorMassachusetts Eye and Ear Infirmary (Other)
ConditionsRecurrent Respiratory Papillomatosis
InterventionsPropranolol (Drug)
Datesstart 2010-01-01, primary completion 2010-09-01, completion 2010-09-01, first posted 2010-01-28, last updated 2013-11-21

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Children treated with propranololExperimentalDrug: Propranolol
  • Propranolol (Drug): Propranolol 2mg/kg divided twice daily

+Outcome measures

Primary outcomes

  • Decreased number of surgeries [3 months]

Secondary outcomes

  • Improved voice quality [3 months]

+Eligibility

Sex: All, ages: 1 Year to 10 Years

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

+Investigators

My Notes