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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subject-Group | Patients suffering from doctors diagnosed bronchiolitis obliterans |
| |
| Control Group | age- and sex matched to subject-group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention - just observational | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| LCI compared to RV/TLC%-pred. | Correlation of these lung function Parameters in patients with BO compared to healthy controls | during Visit 1 (single day, single observation) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | during Visit 1 (single day, single observation) |
| Comparison of low CrP |
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Inclusion Criteria:
informed consent
between 6 and 28 years of age
Known Bronchiolitis obliterans
Ability to perform lung function tests and inhalation
Exclusion Criteria:
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Patients suffering from Bronchiolitis obliterans and controls
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| Name | Affiliation | Role |
|---|---|---|
| Martin Rosewich, MD | Johann Wolfgang Goethe University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital, Goethe-University | Frankfurt am Main | Hesse | 60590 | Germany |
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| Label | URL |
|---|---|
| Kurland G, Michelson P. Bronchiolitis obliterans in children. Pediatr Pulmonol. 2005 Mar;39(3):193-208. Review | View source |
| Smith KJ, Fan LL. Insights into post-infectious bronchiolitis obliterans in children. Thorax. 2006 Jun;61(6):462-3. | View source |
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| ID | Term |
|---|---|
| D001989 | Bronchiolitis Obliterans |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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blood, sputum cells, sputum supernatans
serum parameter for systemic inflammation |
| 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 | 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 | 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 | 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 | 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 | during Visit 1 (single day, single observation) |
| IL-6 (pg/ml) | comparing IL-6 in Serum of patients with BO with healthy controls | during Visit 1 (single day, single observation) |
| IL-8 (pg/ml) | comparing IL-8 in Serum of patients with BO with healthy controls | during Visit 1 (single day, single observation)1 |
| IL-17 (pg/ml) | comparing IL-17 in Serum of patients with BO with healthy controls | 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 | 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 | during Visit 1 |
| IL-17 (mRNA delta-delta-ct) | compare IL-17 mRNA in Sputum cells of patients with BO with healthy controls | 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 | during Visit 1 (single day, single observation) |
| 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. |
| View source |
| Pichler MN, Reichenbach J, Schmidt H, Herrmann G, Zielen S. Severe adenovirus bronchiolitis in children. Acta Paediatr. 2000 Nov;89(11):1387-9. | View source |
| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |