International Plastic Bronchitis Registry

NCT ID: NCT01663948

Last Updated: 2020-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2018-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Plastic Bronchitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with Plastic bronchitis

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosed with Plastic bronchitis
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bruce K Rubin, MEngr, MD, MBA, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Richmond at VCU

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HM14554

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.