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LCI and Bronchial Inflammation in Patients With BO (FRABO-02)

22. juli 2015 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

37

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
    • Hessen
      • Frankfurt am Main, Hessen, Tyskland, 60590
        • Children's Hospital, Goethe-University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 år til 28 år (Barn, Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Faggruppe
Patienter, der lider af læger, diagnosticerede bronchiolitis obliterans
Andet: no intervention - just observational
Kontrolgruppe
alder og køn afstemt efter faggruppe
Andet: no intervention - just observational

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Johann Wolfgang Goethe University Hospital

Efterforskere

  • Ledende efterforsker: Martin Rosewich, MD, Johann Wolfgang Goethe University Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2013

Primær færdiggørelse (Faktiske)

1. november 2013

Studieafslutning (Faktiske)

1. december 2014

Datoer for studieregistrering

Først indsendt

6. juli 2015

Først indsendt, der opfyldte QC-kriterier

8. juli 2015

Først opslået (Skøn)

13. juli 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. juli 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juli 2015

Sidst verificeret

1. juli 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EC 124/13

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Bronchiolitis Obliterans

Kliniske forsøg med no intervention - just observational

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