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Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

Status
Withdrawn
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01058317
Enrollment
0
Registered
2010-01-28
Start date
2010-01-31
Completion date
2010-09-30
Last updated
2013-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Respiratory Papillomatosis

Keywords

respiratory, papilloma, pediatric, juvenile

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.

Interventions

DRUGPropranolol

Propranolol 2mg/kg divided twice daily

Sponsors

Massachusetts Eye and Ear Infirmary
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 10 Years
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

Design outcomes

Primary

MeasureTime frame
Decreased number of surgeries3 months

Secondary

MeasureTime frame
Improved voice quality3 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026