Bronchiolitis ObliteransFRABO-03NCT02627833
Lung Function, LCI, Bronchial Inflammation and Epigenetics of Patients With BO
An observational study of Bronchiolitis Obliterans, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
Bronchiolitis obliterans is a chronic disease in which a persistent inflammatory process leads to obliteration of the small airways. Pulmonary function tests (body plethysmography with DLCO, lung clearance index) are performed and the fraction of exhaled nitric oxide is measured. Read more about this study
- Who is it for?
- Ages 6 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchiolitis Obliterans
- What is being tested?
- observation
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2015to Jul 2016
- 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 6 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients with the assured diagnose of Bronchiolitis Obliterans and controls without this disease.
Who may be able to join
- informed consent
- age between 6 an 35 years
- known bronchiolitis obliterans (Group Bronchiolitis)/ no Bronchiolitis Obliterans (Group matched controls)
- ability to perform lung function tests and inhale correctly
Who cannot join
- <6 years of age
- >35 years of age
- acute systemic or bronchial inflammation
- other chronic diseases or infection (e.g. HIV, Tbc, malignoma)
- pregnancy
- alcohol, drug or illegal drug abuse
- disability to register the range and consequences of the study
- actual participation in another study
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Children's Hospital, Goethe-University
Frankfurt am Main, Hesse, 60590
Martin Rosewich, MD, 49-69-6301 ext. 5381, Martin.Rosewich@kgu.de
Stefan Zielen, MD, PhD, 49-69-6301 ext. 83063, Stefan.Zielen@kgu.de
About this study
Official title: Lungfunction, Lung Clearance Index, Bronchial Inflammation and Epigenetics of Patients With Bronchiolitis Obliterans
Bronchiolitis obliterans is a chronic disease in which a persistent inflammatory process leads to obliteration of the small airways. Pulmonary function tests (body plethysmography with DLCO, lung clearance index) are performed and the fraction of exhaled nitric oxide is measured. A blood test is following to determine the inflammatory status und collect miRNA. Induced Sputum will be obtained.
Read the detailed description
The purpose of this study is to compare miRNA pattern, lung function values, bronchial inflammation and the Lung clearance index of Patients with Bronchiolitis obliterans aged between 6 up to 30 years of age with a matched control group.
The sputum samples will be processed and quantitatively analyzed to get a profile of the cytological composition.
Sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction (qRT-PCR) and by cytometric bead assay (CBA). miRNA samples will be collected, processand compared with the miRNA database at http://www.mirbase.org/
Methods and Work Programme:
- Measurement of nitric oxide in expired air (FeNO)
- Lung function testing with spirometry and body plethysmography
- Lung clearance index (LCI)
- Bronchodilation
- Blood test: blood count, CRP, RAST, serum inflammatory mediators, (genetic markers of the non-specific pulmonary defense system), miRNA analysis
- Induced sputum for inflammatory mediators and microbiological investigations
- Conditions
- Bronchiolitis Obliterans
- Being tested
- observation
- Keywords
- induced Sputum, lung clearance index, miRNA, inflammation, chronic lung disease
- Medical subject headings
- Bronchiolitis Obliterans, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
Record lung function, Lung clearance index, inflammatory status
| Study group | Role | What they receive |
|---|---|---|
| Subject Group | Patients suffering from Bronchiolitis Obliterans Receives: Other: observation | |
| Control Group | Age and sex matched control group Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
miRNA Status
Blood sample to determine candidate miRNA for Bronchiolitis obliterans
Measured: single day observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bronchiolitis ObliteransStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Martin Rosewich, Johann Wolfgang Goethe University Hospital
- Investigators
- Martin Rosewich, MD, Principal investigator, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627833
- Sponsor's protocol ID
- MRosewich
- Acronym
- FRABO-03
- Status last verified
- Dec 2015
- First submitted
- 9 Dec 2015
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kurland G, Michelson P. Bronchiolitis obliterans in children. Pediatr Pulmonol. 2005 Mar;39(3):193-208. doi: 10.1002/ppul.20145.
PubMed 15635614Boehler A, Kesten S, Weder W, Speich R. Bronchiolitis obliterans after lung transplantation: a review. Chest. 1998 Nov;114(5):1411-26. doi: 10.1378/chest.114.5.1411. No abstract available.
PubMed 9824023Moonnumakal SP, Fan LL. Bronchiolitis obliterans in children. Curr Opin Pediatr. 2008 Jun;20(3):272-8. doi: 10.1097/MOP.0b013e3282ff62e9.
PubMed 18475095Pichler M, Herrmann G, Schmidt H, Ahrens P, Zielen S. Persistent adenoviral infection and chronic obstructive bronchitis in children: is there a link? Pediatr Pulmonol. 2001 Nov;32(5):367-71. doi: 10.1002/ppul.1145.
PubMed 11596161Rosewich M, Zissler UM, Kheiri T, Voss S, Eickmeier O, Schulze J, Herrmann E, Ducker RP, Schubert R, Zielen S. Airway inflammation in children and adolescents with bronchiolitis obliterans. Cytokine. 2015 May;73(1):156-62. doi: 10.1016/j.cyto.2014.10.026. Epub 2015 Mar 6.
PubMed 25748838Motameny S, Wolters S, Nurnberg P, Schumacher B. Next Generation Sequencing of miRNAs - Strategies, Resources and Methods. Genes (Basel). 2010 Jun 3;1(1):70-84. doi: 10.3390/genes1010070.
PubMed 24710011
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lungfunction, Lung Clearance Index, Bronchial Inflammation and Epigenetics of Patients With Bronchiolitis Obliterans
- ClinicalTrials.gov ID
- NCT02627833
- Acronym / sponsor ID
- FRABO-03 / MRosewich
- Conditions
- Bronchiolitis Obliterans
- Keywords
- induced Sputum, lung clearance index, miRNA, inflammation, chronic lung disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jul 2016 (estimated)
- First posted
- 11 Dec 2015 (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.
Bronchiolitis obliterans is a chronic disease in which a persistent inflammatory process leads to obliteration of the small airways. Pulmonary function tests (body plethysmography with DLCO, lung clearance index) are performed and the fraction of exhaled nitric oxide is measured. A blood test is following to determine the inflammatory status und collect miRNA. Induced Sputum will be obtained.
Detailed description
The purpose of this study is to compare miRNA pattern, lung function values, bronchial inflammation and the Lung clearance index of Patients with Bronchiolitis obliterans aged between 6 up to 30 years of age with a matched control group.
The sputum samples will be processed and quantitatively analyzed to get a profile of the cytological composition.
Sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction (qRT-PCR) and by cytometric bead assay (CBA). miRNA samples will be collected, processand compared with the miRNA database at http://www.mirbase.org/
Methods and Work Programme:
- Measurement of nitric oxide in expired air (FeNO)
- Lung function testing with spirometry and body plethysmography
- Lung clearance index (LCI)
- Bronchodilation
- Blood test: blood count, CRP, RAST, serum inflammatory mediators, (genetic markers of the non-specific pulmonary defense system), miRNA analysis
- Induced sputum for inflammatory mediators and microbiological investigations
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subject Group | – | Other: observationPatients suffering from Bronchiolitis Obliterans |
| Control Group | – | Other: observationAge and sex matched control group |
Who may qualify
- Ages
- 6 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients with the assured diagnose of Bronchiolitis Obliterans and controls without this disease.
Key inclusion criteria (4 listed)
- informed consent
- age between 6 an 35 years
- known bronchiolitis obliterans (Group Bronchiolitis)/ no Bronchiolitis Obliterans (Group matched controls)
- ability to perform lung function tests and inhale correctly
Key exclusion criteria (8 listed)
- <6 years of age
- >35 years of age
- acute systemic or bronchial inflammation
- other chronic diseases or infection (e.g. HIV, Tbc, malignoma)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationRecord lung function, Lung clearance index, inflammatory status | Other | Control Group, Subject Group |
Primary outcome
miRNA Status
Time frame: single day observation
Blood sample to determine candidate miRNA for Bronchiolitis obliterans
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
- Background: PubMed 15635614Kurland G, Michelson P. Bronchiolitis obliterans in children. Pediatr Pulmonol. 2005 Mar;39(3):193-208. doi: 10.1002/ppul.20145.
- Background: PubMed 9824023Boehler A, Kesten S, Weder W, Speich R. Bronchiolitis obliterans after lung transplantation: a review. Chest. 1998 Nov;114(5):1411-26. doi: 10.1378/chest.114.5.1411. No abstract available.
- Background: PubMed 18475095Moonnumakal SP, Fan LL. Bronchiolitis obliterans in children. Curr Opin Pediatr. 2008 Jun;20(3):272-8. doi: 10.1097/MOP.0b013e3282ff62e9.
- Results publication: PubMed 11596161Pichler M, Herrmann G, Schmidt H, Ahrens P, Zielen S. Persistent adenoviral infection and chronic obstructive bronchitis in children: is there a link? Pediatr Pulmonol. 2001 Nov;32(5):367-71. doi: 10.1002/ppul.1145.
- Results publication: PubMed 25748838Rosewich M, Zissler UM, Kheiri T, Voss S, Eickmeier O, Schulze J, Herrmann E, Ducker RP, Schubert R, Zielen S. Airway inflammation in children and adolescents with bronchiolitis obliterans. Cytokine. 2015 May;73(1):156-62. doi: 10.1016/j.cyto.2014.10.026. Epub 2015 Mar 6.
- Results publication: PubMed 24710011Motameny S, Wolters S, Nurnberg P, Schumacher B. Next Generation Sequencing of miRNAs - Strategies, Resources and Methods. Genes (Basel). 2010 Jun 3;1(1):70-84. doi: 10.3390/genes1010070.
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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.
Martin Rosewich, MD principal investigator
Johann Wolfgang Goethe University Hospital
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 Bronchiolitis Obliterans, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 11 Dec 2015. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Rosewich, MD (+49-69-6301 ext. 5381, Martin.rosewich@kgu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
miRNA Status (time frame: single day observation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02627833, which also lists 6 linked publications.
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 Dec 2015.