LCI and Bronchial Inflammation in Patients With BO (FRABO-02)
22 juli 2015 uppdaterad av: Dr. med. Martin Rosewich, Johann Wolfgang Goethe University Hospital
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Observationell
Inskrivning (Faktisk)
37
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Hessen
-
Frankfurt am Main, Hessen, Tyskland, 60590
- Children's Hospital, Goethe-University
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
6 år till 28 år (Barn, Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Patients suffering from Bronchiolitis obliterans and controls
Beskrivning
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Ämnesgrupp
Patienter som lider av läkare diagnostiserade bronchiolit obliterans
|
|
|
Kontrollgrupp
ålder och kön anpassas till ämnesgrupp
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
LCI compared to RV/TLC%-pred.
Tidsram: during Visit 1 (single day, single observation)
|
Correlation of these lung function Parameters in patients with BO compared to healthy controls
|
during Visit 1 (single day, single observation)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
change of sputum cell count over time (percentage of neutrophils)
Tidsram: during Visit 1 (single day, single observation)
|
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
Tidsram: during Visit 1 (single day, single observation)
|
serum parameter for systemic inflammation
|
during Visit 1 (single day, single observation)
|
|
FVC (%-pred.)
Tidsram: during Visit 1 (single day, single observation)
|
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.)
Tidsram: during Visit 1 (single day, single observation)
|
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
Tidsram: during Visit 1 (single day, single observation)
|
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.)
Tidsram: during Visit 1 (single day, single observation)
|
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.)
Tidsram: during Visit 1 (single day, single observation)
|
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)
Tidsram: during Visit 1 (single day, single observation)
|
comparing IL-6 in Serum of patients with BO with healthy controls
|
during Visit 1 (single day, single observation)
|
|
IL-8 (pg/ml)
Tidsram: during Visit 1 (single day, single observation)1
|
comparing IL-8 in Serum of patients with BO with healthy controls
|
during Visit 1 (single day, single observation)1
|
|
IL-17 (pg/ml)
Tidsram: during Visit 1 (single day, single observation)
|
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)
Tidsram: during Visit 1 (single day, single observation)
|
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)
Tidsram: during Visit 1
|
compare IL-8 mRNA in Sputum cells of patients with BO with healthy controls
|
during Visit 1
|
|
IL-17 (mRNA delta-delta-ct)
Tidsram: during Visit 1 (single day, single observation)
|
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
Tidsram: during Visit 1 (single day, single observation)
|
compare percentage of FOXP3 positive cells in Sputum cells of patients with BO with healthy controls
|
during Visit 1 (single day, single observation)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Martin Rosewich, MD, Johann Wolfgang Goethe University Hospital
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
- Kurland G, Michelson P. Bronchiolitis obliterans in children. Pediatr Pulmonol. 2005 Mar;39(3):193-208. Review
- Smith KJ, Fan LL. Insights into post-infectious bronchiolitis obliterans in children. Thorax. 2006 Jun;61(6):462-3.
- 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.
- Pichler MN, Reichenbach J, Schmidt H, Herrmann G, Zielen S. Severe adenovirus bronchiolitis in children. Acta Paediatr. 2000 Nov;89(11):1387-9.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2013
Primärt slutförande (Faktisk)
1 november 2013
Avslutad studie (Faktisk)
1 december 2014
Studieregistreringsdatum
Först inskickad
6 juli 2015
Först inskickad som uppfyllde QC-kriterierna
8 juli 2015
Första postat (Uppskatta)
13 juli 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
23 juli 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 juli 2015
Senast verifierad
1 juli 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- EC 124/13
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .