Bronchiolitis ObliteransFraboNCT01327248
Clinical Status and Bronchial Inflammation in Patients With Bronchiolitis Obliterans
An observational study of Bronchiolitis Obliterans, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The aim of this case-control study is the characterization of the bronchial and systemic inflammation of children and young adults with bronchiolitis obliterans. On the first visit subjects are asked to perform a lung function test (spirometry, body plethysmography with helium). Read more about this study
- Who is it for?
- Ages 6 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchiolitis Obliterans
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- May 2011to Jun 2012
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study is carried out in children and young adults (6 to 25 years). Both the patients (20) and the healthy subjects (20) are recruited from the outpatient clinic of the departement of Pediatric Allergy and Pulmonology, University Clinic, JW Goethe University, Frankfurt/M, Germany.
Who may be able to join
- informed consent
- between 6 and 25 years of age
- Known bronchiolitis obliterans / no bronchiolitis obliterans(depending on the study group)
- Ability to perform lung function tests and inhalation
Who cannot join
- <6 and > 25 years of age on the day of written informed consent
- Acute illness with systemic or bronchial inflammation
- every chronic condition or infection (eg HIV, tuberculosis, malignancy)
- pregnancy
- known alcohol and/ or drug abuse
- Inability to understand the extent and scope of the study
- Participation in another study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Children's Hospital, Goethe-University
Frankfurt am Main, Hesse, 60590
About this study
The aim of this case-control study is the characterization of the bronchial and systemic inflammation of children and young adults with bronchiolitis obliterans.
On the first visit subjects are asked to perform a lung function test (spirometry, body plethysmography with helium). Further levels of eNO and eCO are determined. A blood sample is drawn to describe the inflammatory status. Bronchial inflammation will be measured in induced sputum. At the second visit, a non-specific bronchial provocation testing (PD20 FEV1 methacholine) is performed.
Read the detailed description
Objectives:
The aim of this study is the characterization of patients with bronchiolitis obliterans in terms of lung function, bronchial hyperreactivity and the degree of the systemic and bronchial inflammation.
Sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction (PCR) (qRT-PCR) and by cytometric bead assay (CBA). Components of the innate immune system (mannose-binding protein, TLR recognition proteins and surfactant proteins) are genetically determined from sputum or blood respectively. In the conduct of this study the investigators will retrospectively and systematically evaluate the available high-resolution computed tomography (HRCT) studies of affected patients
Methods and Work Programme:
This study consists of two study visits (V1 and V2)
V1:
- Measurement of nitric oxide in expired air (eNO)
- Measurement of carbon monoxide in the exhaled air (eCO)
- Lung function testing with spirometry and body plethysmography
- Blood test: blood count, CRP, RAST, serum inflammatory mediators, genetic markers of the non-specific pulmonary defense system
- Induced sputum for inflammatory mediators and microbiological investigations
V2:
- Unspecific bronchial provocation test with methacholine (PD20 FEV1 methacholine)
Study population:
Children and young people (6 - 25 years of age). Both the patients and the healthy subjects are recruited from the outpatient clinic of Pediatric Allergy and Pulmonology.
- Conditions
- Bronchiolitis Obliterans
- Keywords
- Bronchiolitis obliterans, HRCT, Sputum, Blood, Inflammation, adaptive immune system, innate immune system
- 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.
| Study group | Role | What they receive |
|---|---|---|
| affected patients | 20 Patients suffering from bronchiolitis obliterans | |
| non-affected patients | 20 matched controls not suffering from bronchiolitis obliterans |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Cross-sectional
- Enrolment
- 40 participants (actual)
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, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327248
- Sponsor's protocol ID
- FRA-BO
- Acronym
- Frabo
- Status last verified
- Jun 2012
- First submitted
- 30 Mar 2011
- Last updated
- 27 Jun 2012
- 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 15635614Pichler 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 11596161Pichler MN, Reichenbach J, Schmidt H, Herrmann G, Zielen S. Severe adenovirus bronchiolitis in children. Acta Paediatr. 2000 Nov;89(11):1387-9. doi: 10.1080/080352500300002633.
PubMed 11106056Gerhardt SG, McDyer JF, Girgis RE, Conte JV, Yang SC, Orens JB. Maintenance azithromycin therapy for bronchiolitis obliterans syndrome: results of a pilot study. Am J Respir Crit Care Med. 2003 Jul 1;168(1):121-5. doi: 10.1164/rccm.200212-1424BC. Epub 2003 Apr 2.
PubMed 12672648
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Status and Bronchial Inflammation in Patients With Bronchiolitis Obliterans
- ClinicalTrials.gov ID
- NCT01327248
- Acronym / sponsor ID
- Frabo / FRA-BO
- Conditions
- Bronchiolitis Obliterans
- Keywords
- Bronchiolitis obliterans, HRCT, Sputum, Blood, Inflammation, adaptive immune system, innate immune system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 1 Apr 2011 (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 aim of this case-control study is the characterization of the bronchial and systemic inflammation of children and young adults with bronchiolitis obliterans.
On the first visit subjects are asked to perform a lung function test (spirometry, body plethysmography with helium). Further levels of eNO and eCO are determined. A blood sample is drawn to describe the inflammatory status. Bronchial inflammation will be measured in induced sputum. At the second visit, a non-specific bronchial provocation testing (PD20 FEV1 methacholine) is performed.
Detailed description
Objectives:
The aim of this study is the characterization of patients with bronchiolitis obliterans in terms of lung function, bronchial hyperreactivity and the degree of the systemic and bronchial inflammation.
Sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction (PCR) (qRT-PCR) and by cytometric bead assay (CBA). Components of the innate immune system (mannose-binding protein, TLR recognition proteins and surfactant proteins) are genetically determined from sputum or blood respectively. In the conduct of this study the investigators will retrospectively and systematically evaluate the available high-resolution computed tomography (HRCT) studies of affected patients
Methods and Work Programme:
This study consists of two study visits (V1 and V2)
V1:
- Measurement of nitric oxide in expired air (eNO)
- Measurement of carbon monoxide in the exhaled air (eCO)
- Lung function testing with spirometry and body plethysmography
- Blood test: blood count, CRP, RAST, serum inflammatory mediators, genetic markers of the non-specific pulmonary defense system
- Induced sputum for inflammatory mediators and microbiological investigations
V2:
- Unspecific bronchial provocation test with methacholine (PD20 FEV1 methacholine)
Study population:
Children and young people (6 - 25 years of age). Both the patients and the healthy subjects are recruited from the outpatient clinic of Pediatric Allergy and Pulmonology.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| affected patients | – | –20 Patients suffering from bronchiolitis obliterans |
| non-affected patients | – | –20 matched controls not suffering from bronchiolitis obliterans |
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study is carried out in children and young adults (6 to 25 years). Both the patients (20) and the healthy subjects (20) are recruited from the outpatient clinic of the departement of Pediatric Allergy and Pulmonology, University Clinic, JW Goethe University, Frankfurt/M, Germany.
Key inclusion criteria (4 listed)
- informed consent
- between 6 and 25 years of age
- Known bronchiolitis obliterans / no bronchiolitis obliterans(depending on the study group)
- Ability to perform lung function tests and inhalation
Key exclusion criteria (7 listed)
- <6 and > 25 years of age on the day of written informed consent
- Acute illness with systemic or bronchial inflammation
- every chronic condition or infection (eg HIV, tuberculosis, malignancy)
- pregnancy
- known alcohol and/ or drug abuse
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2012.
- 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 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.
- Background: PubMed 11106056Pichler MN, Reichenbach J, Schmidt H, Herrmann G, Zielen S. Severe adenovirus bronchiolitis in children. Acta Paediatr. 2000 Nov;89(11):1387-9. doi: 10.1080/080352500300002633.
- Background: PubMed 12672648Gerhardt SG, McDyer JF, Girgis RE, Conte JV, Yang SC, Orens JB. Maintenance azithromycin therapy for bronchiolitis obliterans syndrome: results of a pilot study. Am J Respir Crit Care Med. 2003 Jul 1;168(1):121-5. doi: 10.1164/rccm.200212-1424BC. Epub 2003 Apr 2.
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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
Goethe University
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 7 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: finished, as of the sponsor's last update on 27 Jun 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01327248, which also lists 4 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 27 Jun 2012.