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Research to Evaluate a Possible Relation Between Values Obtained After Processing CT Images, Lung Function Tests and the Experience of the Patient During an Exacerbation in COPD Patients.

26. november 2014 opdateret af: FLUIDDA nv

Correlation of Functional Respiratory Imaging Parameters With Lung Function Parameters and Patient Reported Outcome Measures During Exacerbation of COPD.

In this study the consequences of exacerbations will be visualized by high resolution computed tomography (HRCT) scan at functional residual capacity (FRC) and total lung capacity (TLC) as taken during an episode of exacerbation and after recovering. Changes in HRCT based airway dimensions and computational fluid dynamic (CFD) -based resistance values will be correlated with changes in patient reported outcomes (PROs) and lung function tests recorded at the same time.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

53

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Belgien
    • Antwerp
      • Edegem, Antwerp, Belgien, 2650
        • Antwerp University Hospital
  • Holland
      • Groningen, Holland, 9700RB
        • University Medical Center Groningen
      • Maastricht, Holland, 6229HX
        • Maastricht University Medical Center
  • Italien
      • Florence, Italien, 50134
        • University of Florence

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

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male or female, ≥ 40 years old
  • COPD as defined by the global Initiative on obstructive lung disease4
  • Post-bronchodilator FEV1/FVC < 70% AND post-bronchodilator FEV1 <80%pred as documented in the last 5 years.
  • Smoking history of at least 10 pack-years
  • At entry in the study experiencing an exacerbation defined as an acute change in the patient 's baseline dyspnea, cough, and/or sputum that is beyond normal day to day variations, and that necessitates the administration or doubling of systemic corticosteroid treatment.
  • Patients must be able to understand and complete protocol requirements, instructions, questionnaires and protocol-stated restrictions.
  • Written and signed informed consent

Exclusion Criteria:

  • Pregnant or lactating females
  • Patient diagnosed with asthma
  • Patient with pneumonia as defined radiologically at the start of the exacerbation
  • Patient with a history of or presence of lung cancer
  • Patient with an indication for non-invasive ventilation
  • Patient unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
  • Patient who received any investigational new drug within the last 4 weeks prior to visit 1.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: No treatment
CT-scans will be taken in the study. The EC of the University hospital antwerp considers this as an intervention.
Stråling: Functional Respiratory Imaging
HRCT scan at FRC and TLC as taken during an episode of exacerbation and after recovering.
Andre navne:
  • HRCT-scanning

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in functional respiratory imaging parameters
Tidsramme: Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
The primary objective of this study is to evaluate whether changes in HRCT based airway dimensions and Computational Fluid Dynamic (CFD)-based resistance values correlate with changes in lung function parameters, under the conditions of exacerbation of COPD as well as after recovering from exacerbation.
Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
Changes in lung function parameters
Tidsramme: Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
The primary objective of this study is to evaluate whether changes in HRCT based airway dimensions and Computational Fluid Dynamic (CFD)-based resistance values correlate with changes in lung function parameters, under the conditions of exacerbation of COPD as well as after recovering from exacerbation.
Baseline (= during exacerbation) and after about 6 weeks (= after recovering)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in patient reported outcome (PRO) measures
Tidsramme: Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
The secondary objective is to check if the changes in CFD data actually correlate better with changes in PRO than changes in lung function parameters.
Baseline (= during exacerbation) and after about 6 weeks (= after recovering)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Reproducibility of segmentation
Tidsramme: Within 1 month of visit
As tertiary objective the reproducibility of the segmentations done by the centers will be evaluated. To accomplish reproducible segmentations the multiple centers will be guided to perform accurate segmentations, and bottlenecks in the usage of the program will be identified and resolved in order to simplify it where necessary and possible.
Within 1 month of visit

Samarbejdspartnere og efterforskere

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

Sponsor

FLUIDDA nv

Efterforskere

  • Ledende efterforsker: Huib AM Kerstjens, MD, University Medical Center Groningen
  • Ledende efterforsker: Emiel FM Wouters, MD, Maastricht University Medical Center
  • Ledende efterforsker: Massimo Pistolesi, MD, University of Florence

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. september 2012

Primær færdiggørelse (Faktiske)

1. september 2014

Studieafslutning (Faktiske)

1. september 2014

Datoer for studieregistrering

Først indsendt

6. september 2012

Først indsendt, der opfyldte QC-kriterier

10. september 2012

Først opslået (Skøn)

13. september 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. december 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. november 2014

Sidst verificeret

1. november 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FLUI-2011-79

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 .

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