Plastic BronchitisNCT01663948
International Plastic Bronchitis Registry
An observational study of Plastic Bronchitis, run by Virginia Commonwealth University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Plastic Bronchitis
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to 1 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study is open to patients around the world suffering from Plastic bronchitis
Who may be able to join
- Diagnosed with Plastic bronchitis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
Read the 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.
- Conditions
- Plastic Bronchitis
- Keywords
- Plastic bronchitis, PB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Plastic bronchitis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2012 (estimated)
- Study startJul 2012
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Why it stopped: Loss of staff combined with low study enrollment and a change in lab/PI priorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plastic BronchitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruce K Rubin, MEngr, MD, MBA, FRCPC, Principal investigator, Children's Hospital of Richmond at VCU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663948
- Sponsor's protocol ID
- HM14554
- Status last verified
- Mar 2020
- First submitted
- 9 Aug 2012
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Plastic Bronchitis Registry
- ClinicalTrials.gov ID
- NCT01663948
- Acronym / sponsor ID
- HM14554
- Conditions
- Plastic Bronchitis
- Keywords
- Plastic bronchitis, PB
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Loss of staff combined with low study enrollment and a change in lab/PI priorities
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 14 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Plastic bronchitis | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study is open to patients around the world suffering from Plastic bronchitis
Key inclusion criteria (1 listed)
- Diagnosed with Plastic bronchitis
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Loss of staff combined with low study enrollment and a change in lab/PI priorities). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
Related trials for Plastic Bronchitis
RecruitingObservational study
European Registry Study on Lymphatic Interventions
Lymphatic Disorders, Plastic Bronchitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce K Rubin, MEngr, MD, MBA, FRCPC principal investigator
Children's Hospital of Richmond at VCU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plastic Bronchitis, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Loss of staff combined with low study enrollment and a change in lab/PI priorities). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
natural course and long term health outcomes (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.