Bronchiolitis ObliteransFRABO-02NCT01633385
Bronchial Inflammation in Patients With Bronchiolithis Obliterans
An observational study of Bronchiolitis Obliterans, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The investigators plan to study the variability of lung function parameters and bronchial inflammatory markers in 20 patients with bronchiolitis obliterans at the age of 6 to 25 years compared with an age- and sex-matched control group. 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
- 37 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2012to Dec 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: Patients suffering from Bronchiolitis obliterans and controls
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
- 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
Official title: Lung Function and Bronchial Inflammation in Patients With Bronchiolithis Obliterans
The investigators plan to study the variability of lung function parameters and bronchial inflammatory markers in 20 patients with bronchiolitis obliterans at the age of 6 to 25 years compared with an age- and sex-matched control group. The investigators will perform a pulmonary function test (body plethysmography with TLCO), and measure the fraction of exhaled nitric oxide (eNO). Further a blood sample is drawn to determine the systemic inflammation. Finally induced sputum is collected and a cell count is performed, and cells and supernatants are analyzed for inflammatory markers. This investigation will be repeated after 4-6 weeks. The aim of this study is to define baseline values and the variability of possible outcome parameters for future interventional studies.
Read the detailed description
The purpose of this study is to characterize the variability of lung function values and bronchial inflammation of 20 Patients with Bronchiolitis obliterans aged between 6 up to 25 years. The patients' data will be compared with the results of a reference group with similar age conditions to determine possible outcome-parameters for following interventional studies.
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 (PCR) (qRT-PCR) and by cytometric bead assay (CBA).)
Methods and Work Programme:
This study consists of two study visits (V1 and V2)
V1:
- Measurement of nitric oxide in expired air (eNO)
- Lung function testing with spirometry and body plethysmography
- Bronchodilation
- 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:
- Measurement of nitric oxide in expired air (eNO)
- Lung function testing with spirometry and body plethysmography
- Bronchodilation
- Lung function testing with spirometry and body plethysmography
- Induced sputum for inflammatory mediators and microbiological investigations
- Conditions
- Bronchiolitis Obliterans
- Keywords
- bronchial inflammation, Bronchiolitis obliterans, 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 |
|---|---|---|
| Subject-Group | Patients suffering from doctors diagnosed bronchiolitis obliterans | |
| Control Group | age- and sex matched to subject-group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of FEF75 over time
Look for changes/ variability of this lung function parameter
Measured: V1: Day 1 - V2: Day 28-42
Secondary outcomes (2)
change of sputum cell count over time
induced sputum will be analyzed for different cellular components such as alveolar macrophages, neutrophils, lymphocytes and others. Epithelial cells will be excluded
Measured: V1: Day 1 - V2: Day 28-42
change of low CrP over time
serum parameter for systemic inflammation
Measured: V1: Day 1 - V2: Day 28-42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 37 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633385
- Sponsor's protocol ID
- BO2012-02
- Acronym
- FRABO-02
- Status last verified
- Apr 2013
- First submitted
- 26 Jun 2012
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Function and Bronchial Inflammation in Patients With Bronchiolithis Obliterans
- ClinicalTrials.gov ID
- NCT01633385
- Acronym / sponsor ID
- FRABO-02 / BO2012-02
- Conditions
- Bronchiolitis Obliterans
- Keywords
- bronchial inflammation, Bronchiolitis obliterans, Sputum, Blood, Inflammation, adaptive immune system, innate immune system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Jul 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 investigators plan to study the variability of lung function parameters and bronchial inflammatory markers in 20 patients with bronchiolitis obliterans at the age of 6 to 25 years compared with an age- and sex-matched control group. The investigators will perform a pulmonary function test (body plethysmography with TLCO), and measure the fraction of exhaled nitric oxide (eNO). Further a blood sample is drawn to determine the systemic inflammation. Finally induced sputum is collected and a cell count is performed, and cells and supernatants are analyzed for inflammatory markers. This investigation will be repeated after 4-6 weeks. The aim of this study is to define baseline values and the variability of possible outcome parameters for future interventional studies.
Detailed description
The purpose of this study is to characterize the variability of lung function values and bronchial inflammation of 20 Patients with Bronchiolitis obliterans aged between 6 up to 25 years. The patients' data will be compared with the results of a reference group with similar age conditions to determine possible outcome-parameters for following interventional studies.
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 (PCR) (qRT-PCR) and by cytometric bead assay (CBA).)
Methods and Work Programme:
This study consists of two study visits (V1 and V2)
V1:
- Measurement of nitric oxide in expired air (eNO)
- Lung function testing with spirometry and body plethysmography
- Bronchodilation
- 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:
- Measurement of nitric oxide in expired air (eNO)
- Lung function testing with spirometry and body plethysmography
- Bronchodilation
- Lung function testing with spirometry and body plethysmography
- 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 | – | –Patients suffering from doctors diagnosed bronchiolitis obliterans |
| Control Group | – | –age- and sex matched to subject-group |
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients suffering from Bronchiolitis obliterans and controls
Key inclusion criteria (5 listed)
- informed consent
- between 6 and 25 years of age
- Known Bronchiolitis obliterans
- Ability to perform lung function tests and inhalation
Key exclusion criteria (6 listed)
- 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
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
Change of FEF75 over time
Time frame: V1: Day 1 - V2: Day 28-42
Look for changes/ variability of this lung function parameter
2 secondary outcomes
change of sputum cell count over time
Time frame: V1: Day 1 - V2: Day 28-42
change of low CrP over time
Time frame: V1: Day 1 - V2: Day 28-42
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 4 Apr 2013.
- Kurland G, Michelson P. Bronchiolitis obliterans in children. Pediatr Pulmonol. 2005 Mar;39(3):193-208. ReviewLink provided by the sponsor.
- Smith KJ, Fan LL. Insights into post-infectious bronchiolitis obliterans in children. Thorax. 2006 Jun;61(6):462-3.Link provided by the sponsor.
- Pichler 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.Link provided by the sponsor.
- Pichler MN, Reichenbach J, Schmidt H, Herrmann G, Zielen S. Severe adenovirus bronchiolitis in children. Acta Paediatr. 2000 Nov;89(11):1387-9.Link provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 5 inclusion and 6 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 4 Apr 2013. 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.
What does the primary outcome measure?
Change of FEF75 over time (time frame: V1: Day 1 - V2: Day 28-42). 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 4 Apr 2013; AzTrials last refreshed its copy on 6 Nov 2026.