Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis - Full Text View

Sponsor:	Massachusetts Eye and Ear Infirmary
Information provided by:	Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:	NCT01058317

Purpose

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	Intervention	Phase
Recurrent Respiratory Papillomatosis	Drug: Propranolol	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Control: Historical Control Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

Resource links provided by NLM:

Drug Information available for: Propranolol hydrochloride Propranolol Dexpropranolol

U.S. FDA Resources

Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:

Decreased number of surgeries [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improved voice quality [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	January 2010
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Children treated with propranolol: Experimental	Drug: Propranolol Propranolol 2mg/kg divided twice daily

Eligibility

Ages Eligible for Study:	1 Year to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Massachusetts Eye and Ear Infirmary ( Christopher Hartnick, Associate Professor, Otolaryngology )
ClinicalTrials.gov Identifier:	NCT01058317 History of Changes
Other Study ID Numbers:	09-10-104
Study First Received:	January 27, 2010
Last Updated:	January 27, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts Eye and Ear Infirmary:

respiratory, papilloma, pediatric, juvenile

Additional relevant MeSH terms:

Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Propranolol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

Pharmacologic Actions
Antihypertensive Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents

ClinicalTrials.gov processed this record on September 01, 2010