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Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis


Phase 2/Phase 3
1 Year
10 Years
Not Enrolling
Both
Recurrent Respiratory Papillomatosis

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Trial Information

Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Decreased number of surgeries

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Christopher Hartnick, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts Eye and Ear Infirmary

Authority:

United States: Institutional Review Board

Study ID:

09-10-104

NCT ID:

NCT01058317

Start Date:

January 2010

Completion Date:

September 2010

Related Keywords:

  • Recurrent Respiratory Papillomatosis
  • respiratory, papilloma, pediatric, juvenile
  • Papilloma
  • Respiratory Tract Infections
  • Papillomavirus Infections

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