LCI and Bronchial Inflammation in Patients With BO (FRABO-02)
22. juli 2015 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Studietype
Observasjonsmessig
Registrering (Faktiske)
37
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Hessen
-
Frankfurt am Main, Hessen, Tyskland, 60590
- Children's Hospital, Goethe-University
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
6 år til 28 år (Barn, Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Patients suffering from Bronchiolitis obliterans and controls
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Faggruppe
Pasienter som lider av leger diagnostiserte bronchiolitis obliterans
|
|
|
Kontrollgruppe
alder og kjønn tilpasset faggruppe
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
LCI compared to RV/TLC%-pred.
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
change of sputum cell count over time (percentage of neutrophils)
Tidsramme: 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
Tidsramme: during Visit 1 (single day, single observation)
|
serum parameter for systemic inflammation
|
during Visit 1 (single day, single observation)
|
|
FVC (%-pred.)
Tidsramme: 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.)
Tidsramme: 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
Tidsramme: 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.)
Tidsramme: 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.)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Martin Rosewich, MD, Johann Wolfgang Goethe University Hospital
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2013
Primær fullføring (Faktiske)
1. november 2013
Studiet fullført (Faktiske)
1. desember 2014
Datoer for studieregistrering
Først innsendt
6. juli 2015
Først innsendt som oppfylte QC-kriteriene
8. juli 2015
Først lagt ut (Anslag)
13. juli 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
23. juli 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. juli 2015
Sist bekreftet
1. juli 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EC 124/13
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .