Bronchiolitis ObliteransFRABO-02NCT02495597
LCI and Bronchial Inflammation in Patients With BO
An observational study of Bronchiolitis Obliterans, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The investigators here compare lung function parameters (RV, RV/TLC and FEF75) with the results of the Lung Clearance index (LCI) . Further this study evaluates bronchial inflammatory markers in 20 patients with bronchiolitis obliterans at the age of 6 to 28 years compared with an age- and sex-matched control group. Read more about this study
- Who is it for?
- Ages 6 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchiolitis Obliterans
- How many people
- 37 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2013to Dec 2014
- 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 28 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 28 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 Clearance Index (LCI) and Bronchial Inflammation in Patients With Bronchiolitis Obliterans (BO)
The investigators here compare lung function parameters (RV, RV/TLC and FEF75) with the results of the Lung Clearance index (LCI) . Further this study evaluates bronchial inflammatory markers in 20 patients with bronchiolitis obliterans at the age of 6 to 28 years compared with an age- and sex-matched control group. The investigators will perform a pulmonary function test (body plethysmography with DLCO) and compare the results with the LCI. Further we will measure the fraction of exhaled nitric oxide (FeNO) and draw a blood sample to determine the level of systemic inflammation. Finally induced sputum is collected and a cell count is performed, and cells and supernatants are analyzed for inflammatory markers. This study will set baseline markers for future interventional studies.
Read the detailed description
The purpose of this study is to compare lung function values with the Lung clearance index of 20 Patients with Bronchiolitis obliterans aged between 6 up to 28 years. Further we aim to compare the bronchial Inflammation between the patients and 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:
- 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)
- Induced sputum for inflammatory mediators and microbiological investigations
- Conditions
- Bronchiolitis Obliterans
- Being tested
- no intervention - just observational
- 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.
no intervention - just observationalOther
| Study group | Role | What they receive |
|---|---|---|
| Subject-Group | Patients suffering from doctors diagnosed bronchiolitis obliterans Receives: Other: no intervention - just observational | |
| Control Group | age- and sex matched to subject-group Receives: Other: no intervention - just observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
LCI compared to RV/TLC%-pred.
Correlation of these lung function Parameters in patients with BO compared to healthy controls
Measured: during Visit 1 (single day, single observation)
Secondary outcomes (14)
change of sputum cell count over time (percentage of neutrophils)
induced sputum will be analyzed for different cellular components such as alveolar macrophages, neutrophils, lymphocytes and others. Epithelial cells will be excluded
Measured: during Visit 1 (single day, single observation)
Comparison of low CrP
serum parameter for systemic inflammation
Measured: during Visit 1 (single day, single observation)
FVC (%-pred.)
To compare FVC (%-pred.)of patients suffering from BO with FVC (%-pred.)of a healthy control group
Measured: during Visit 1 (single day, single observation)
FEV1 (%-pred.)
To compare FEV1 (%-pred.)of patients suffering from BO withFEV1 (%-pred.)of a healthy control group
Measured: during Visit 1 (single day, single observation)
Tiffeneau-Index
To compare Tiffeneau-Index of patients suffering from BO with Tiffeneau-Index of a healthy control group
Measured: during Visit 1 (single day, single observation)
sRtot (%-pred.)
To compare sRtot (%-pred.) of patients suffering from BO with sRtot (%-pred.) of a healthy control group
Measured: during Visit 1 (single day, single observation)
RV/TLC (%-pred.)
To compare RV/TLC (%-pred.) of patients suffering from BO with RV/TLC (%-pred.) of a healthy control group
Measured: during Visit 1 (single day, single observation)
IL-6 (pg/ml)
comparing IL-6 in Serum of patients with BO with healthy controls
Measured: during Visit 1 (single day, single observation)
IL-8 (pg/ml)
comparing IL-8 in Serum of patients with BO with healthy controls
Measured: during Visit 1 (single day, single observation)1
IL-17 (pg/ml)
comparing IL-17 in Serum of patients with BO with healthy controls
Measured: during Visit 1 (single day, single observation)
IL-6 (mRNA delta-delta-ct)
compare IL-6 mRNA in Sputum cells of patients with BO with healthy controls
Measured: during Visit 1 (single day, single observation)
IL-8 (mRNA delta-delta-ct)
compare IL-8 mRNA in Sputum cells of patients with BO with healthy controls
Measured: during Visit 1
IL-17 (mRNA delta-delta-ct)
compare IL-17 mRNA in Sputum cells of patients with BO with healthy controls
Measured: during Visit 1 (single day, single observation)
Percentage of FOXP3 positive cells in Sputum
compare percentage of FOXP3 positive cells in Sputum cells of patients with BO with healthy controls
Measured: during Visit 1 (single day, single observation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startApr 2013
- Primary completionNov 2013
- Study completionDec 2014
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
- Investigators
- Martin Rosewich, MD, Principal investigator, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495597
- Sponsor's protocol ID
- EC 124/13
- Acronym
- FRABO-02
- Status last verified
- Jul 2015
- First submitted
- 6 Jul 2015
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Clearance Index (LCI) and Bronchial Inflammation in Patients With Bronchiolitis Obliterans (BO)
- ClinicalTrials.gov ID
- NCT02495597
- Acronym / sponsor ID
- FRABO-02 / EC 124/13
- 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 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Jul 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.
The investigators here compare lung function parameters (RV, RV/TLC and FEF75) with the results of the Lung Clearance index (LCI) . Further this study evaluates bronchial inflammatory markers in 20 patients with bronchiolitis obliterans at the age of 6 to 28 years compared with an age- and sex-matched control group. The investigators will perform a pulmonary function test (body plethysmography with DLCO) and compare the results with the LCI. Further we will measure the fraction of exhaled nitric oxide (FeNO) and draw a blood sample to determine the level of systemic inflammation. Finally induced sputum is collected and a cell count is performed, and cells and supernatants are analyzed for inflammatory markers. This study will set baseline markers for future interventional studies.
Detailed description
The purpose of this study is to compare lung function values with the Lung clearance index of 20 Patients with Bronchiolitis obliterans aged between 6 up to 28 years. Further we aim to compare the bronchial Inflammation between the patients and 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:
- 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)
- 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: no intervention - just observationalPatients suffering from doctors diagnosed bronchiolitis obliterans |
| Control Group | – | Other: no intervention - just observationalage- and sex matched to subject-group |
Who may qualify
- Ages
- 6 to 28 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 28 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention - just observational | Other | Control Group, Subject-Group |
Primary outcome
LCI compared to RV/TLC%-pred.
Time frame: during Visit 1 (single day, single observation)
Correlation of these lung function Parameters in patients with BO compared to healthy controls
14 secondary outcomes
change of sputum cell count over time (percentage of neutrophils)
Time frame: during Visit 1 (single day, single observation)
Comparison of low CrP
Time frame: during Visit 1 (single day, single observation)
FVC (%-pred.)
Time frame: during Visit 1 (single day, single observation)
FEV1 (%-pred.)
Time frame: during Visit 1 (single day, single observation)
Tiffeneau-Index
Time frame: during Visit 1 (single day, single observation)
sRtot (%-pred.)
Time frame: during Visit 1 (single day, single observation)
RV/TLC (%-pred.)
Time frame: during Visit 1 (single day, single observation)
IL-6 (pg/ml)
Time frame: during Visit 1 (single day, single observation)
IL-8 (pg/ml)
Time frame: during Visit 1 (single day, single observation)1
IL-17 (pg/ml)
Time frame: during Visit 1 (single day, single observation)
IL-6 (mRNA delta-delta-ct)
Time frame: during Visit 1 (single day, single observation)
IL-8 (mRNA delta-delta-ct)
Time frame: during Visit 1
IL-17 (mRNA delta-delta-ct)
Time frame: during Visit 1 (single day, single observation)
Percentage of FOXP3 positive cells in Sputum
Time frame: during Visit 1 (single day, single observation)
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 23 Jul 2015.
- 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.
Related trials for Bronchiolitis Obliterans
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
A New ECP Protocol for the Treatment of cGVHD
Chronic Graft Versus Host Disease
Active, not recruitingPhase 1/2
Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation
Chronic Graft vs Host Disease, Chronic Graft-Versus-Host Disease
RecruitingPhase 1
Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD
Graft Versus Host Disease (cGvHD)
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 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 23 Jul 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?
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?
LCI compared to RV/TLC%-pred. (time frame: during Visit 1 (single day, single observation)). 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 23 Jul 2015.