Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01663948
Other study ID # HM14554
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date July 2012
Est. completion date November 1, 2018

Study information

Verified date March 2020
Source Virginia Commonwealth University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

Plastic bronchitis (PB) 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,chronic obstructive pulmonary disease , 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.


Recruitment information / eligibility

Status Terminated
Enrollment 23
Est. completion date November 1, 2018
Est. primary completion date November 1, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Diagnosed with Plastic bronchitis

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Virginia Commonwealth University Richmond Virginia

Sponsors (1)

Lead Sponsor Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary natural course and long term health outcomes The purpose of the intrnational plastic bronchitis registry is to understand the natural course and long term health outcomes of patients diagnosed with plastic bronchitis. This provides essential data for identifying possible causes of this disease and potential treatments. ongoing
See also
  Status Clinical Trial Phase
Recruiting NCT03942926 - The Efficacy and Safety of Sirolimus for Plastic Bronchitis Phase 2
Completed NCT02315898 - Inhaled Tissue Plasminogen Activator for Acute Plastic Bronchitis Phase 2
Completed NCT04163653 - Lymphatic Morphology of Fontan Patients