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International Plastic Bronchitis Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01663948
Recruitment Status : Terminated (Loss of staff combined with low study enrollment and a change in lab/PI priorities)
First Posted : August 14, 2012
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief 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.

Condition or disease
Plastic Bronchitis

Detailed 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.

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Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Plastic Bronchitis Registry
Study Start Date : July 2012
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acute Bronchitis

Group/Cohort
Patients with Plastic bronchitis



Primary Outcome Measures :
  1. natural course and long term health outcomes [ Time Frame: ongoing ]
    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.


Biospecimen Retention:   Samples With DNA
Airway Casts


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663948


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Bruce K Rubin, MEngr, MD, MBA, FRCPC Children's Hospital of Richmond at VCU

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01663948    
Other Study ID Numbers: HM14554
First Posted: August 14, 2012    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Virginia Commonwealth University:
Plastic bronchitis
PB
Additional relevant MeSH terms:
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Bronchitis
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes