International Plastic Bronchitis Registry

This study is currently recruiting participants.

Verified August 2012 by Virginia Commonwealth University

Sponsor:

Information provided by (Responsible Party):

Virginia Commonwealth University

ClinicalTrials.gov Identifier:

NCT01663948

First received: August 9, 2012

Last updated: August 13, 2012

Last verified: August 2012

History of Changes

Purpose

The purpose of the international plastic bronchitis registry is to understand the natural course and long term health outcomes of subjects diagnosed with plastic bronchitis due to different types of casts. This provides essential data for identifying best practices and treatments. The secondary aim is to understand the structure of casts and mechanism of their formation.

Condition
Plastic Bronchitis

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	International Plastic Bronchitis Registry

Further study details as provided by Virginia Commonwealth University:

Biospecimen Retention: Samples With DNA

Airway Casts

Estimated Enrollment:	100
Study Start Date:	July 2012
Estimated Study Completion Date:	July 2022
Estimated Primary Completion Date:	July 2022 (Final data collection date for primary outcome measure)

Groups/Cohorts
Patients with Plastic bronchitis

Detailed Description:

Plastic bronchitis patients have casts removed during bronchoscopy as part of their routine care or that they are able to expectorate (cough out) casts naturally. The casts are normally discarded. Patients that agree to participate in the registry ship the airway casts and medical history to Dr. Bruce Rubin's Research Laboratory at Virginia Commonwealth University Richmond Virginia, USA.

The lab evaluates the biopolymer composition and structure of the airway casts by immunohistochemistry in order to identify microscopic differences between expectorated casts of subjects with plastic bronchitis and sputum from other populations (cystic fibrosis, COPD, and normal airways). The lab also conducts in vitro evaluation of clearability, adhesivity, cohesivity, and inflammatory mediator concentrations to better understand the nature of the disease.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The study is open to patients around the world suffering from Plastic bronchitis

Criteria

Inclusion Criteria:

Diagnosed with Plastic bronchitis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01663948

Contacts

Contact: Melissa A Yopp, B.S	804-628-2793	mayopp@vcu.edu
Contact: Shauna Webb-Parker, M.S	8046282795	webbparkersr@vcu.edu

Locations

United States, Virginia
Virginia Commonwealth University	Recruiting
Richmond, Virginia, United States, 23298
Contact: Melissa Yopp, B.S 8046282793 mayopp@vcu.edu
Contact: Shauna Webb-Parker, M.S 8046282795 webbparkersr@vcu.edu
Principal Investigator: Bruce k Rubin, MEngr, MD, MBA, FRCPC

Sponsors and Collaborators

Virginia Commonwealth University

Investigators

Principal Investigator:

Bruce K Rubin, MEngr, MD, MBA, FRCPC

Children's Hospital of Richmond at VCU

More Information

No publications provided

Responsible Party:	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT01663948 History of Changes
Other Study ID Numbers:	HM14554
Study First Received:	August 9, 2012
Last Updated:	August 13, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:

Plastic bronchitis
PB

Additional relevant MeSH terms:

Bronchitis
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive

Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013

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