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Pathogenetic Mechanisms of Chronic Obstructive Pulmonary Diseases (CAPTA)

11. april 2012 opdateret af: Raimundas Sakalauskas, Lithuanian University of Health Sciences

Evaluation of Pathogenetic Mechanisms of Chronic Obstructive Pulmonary Diseases

Asthma and chronic obstructive pulmonary disease(COPD) are common diseases, which tend to even increase in many countries. Both from a clinical and a pathophysiological point of view, this is an important issue. However, an understanding of the relationship between the complex array of cells and mediators involved in asthma and COPD is not yet fully dissected which makes difficult to find a specific and sensitive panel of biomarkers that can reflect intensity of these pathological processes and can help to predict the individual outcome.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Objectives:

To evaluate the patterns of pathophysiology and genetic predisposition of COPD and asthma

Tasks:

To evaluate patients that respond to corticosteroids and those who do not

Compare the inflammatory markers:

  • of COPD and asthma patients before and after treatment with inhaled glucocorticoids
  • of COPD and asthma patients that respond to inhaled glucocorticoids and those who do not
  • of nonsmokers and smokers asthma patients

To identify a small set of markers that can be used to predict corticosteroid-treatment response in patients with COPD.

To evaluate epigenetic factors

To compare gene mutation and polymorphism between study groups

To evaluate the relationship between genetic predisposition and pathophysiology, clinical symptoms

To evaluate the relationship between patterns of pathophysiology and clinical symptoms, lung function, quality of life in patients with chronic obstructive pulmonary diseases.

Visit 1 Written informed consent will be obtained

  • A full medical, surgical, smoking, labour history. A physical examination will be performed
  • Resting SaO2 will be measured, exhaled nitric oxide (FENO)
  • Chest X-ray
  • Patient will fulfil questionnaires
  • Spirometry and bronchodilatation test
  • Sputum induction and samples will be performed

Visit 2 • Blood samples for blood clotting test and immunological markers will be taken• Cough inhalation challenge

Visit 3

  • Patient will be hospitalized to the Department of Pulmonology and Immunology
  • Blood samples for genetic analysis will be taken
  • Urinary samples will be taken• Methacholine challenge test Polysomnography
  • Bronchoscopy (biopsy and BAL)
  • Study drug administration

Visit 4 and 5

  • Adverse events, COPD or asthma exacerbation, concomitant medications will be recorded, exhaled nitric oxide (FENO)
  • Spirometry
  • Patient will fulfil questionnaires
  • Cough inhalation challenge

Visit 6

  • Patient will fulfil questionnaires
  • Spirometry and bronchodilatation test.
  • Sputum induction and samples will be performed

Visit 7

• Blood samples for blood clotting test, immunological and genetic analysis will be taken• Cough inhalation challenge

Visit 8

  • Patient will be hospitalized to the Department of Pulmonology and Immunology
  • Urinary samples will be taken• Methacholine challenge test Polysomnography
  • Bronchoscopy (biopsy and BAL)
  • Further treatment administration

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

200

Fase

  • Ikke anvendelig

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

30 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male or female outpatients aged 40-80 years inclusive.
  • An established clinical history of COPD as defined by the GOLD guidelines.
  • COPD patients with a baseline (pre-bronchodilator) FEV1 40-80% of predicted normal value; post-bronchodilator FEV1/FVC ratio ≤ 70% predicted.
  • COPD patients with a smoking history (current or ex-smoker) of ≥10 pack years or those who have exposure to occupational dust and chemicals
  • An established clinical history of asthma defined by the GINA recommendations.
  • Subjects with out hypoxemia (all subjects must have an O2 saturation ≥88% on room air).

Control (healthy) subjects with baseline FEV1 >80% of predicted normal value

  • A female is eligible to participate this study if she is of non-childbearing potential, or childbearing potential has a negative pregnancy test.
  • Patients who did not use inhaled and oral corticosteroids 6 weeks and/or long acting bronchodilators 4 weeks before study.

Exclusion Criteria:

  • There is a current respiratory disorder other than COPD and asthma (e.g. lung cancer, sarcoidosis, active tuberculosis etc.)
  • Subjects who have had a COPD and asthma exacerbation or respiratory infection in the 4 weeks before Visit 1.
  • Subjects with a chest X-ray indicating diagnosis other than COPD or asthma that might interfere with the study.
  • Subjects who are unable to stop treatment with inhaled, and oral corticosteroids 6 weeks and/or long acting bronchodilators 4 weeks before study.
  • Subjects receiving treatment with cromolyn sodium or nedocromil, oral beta2 - agonists, long acting anticholinergic, leucotriene modifiers
  • Subjects who have had lung surgery.
  • Subjects with bleeding diathesis.
  • Subjects receiving treatment with long-term oxygen therapy.
  • Subjects with serious, uncontrolled diseases those are uncontrolled on permitted therapy.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Budesonide
patients who gave their agreement were randomised to 3 months treatment with either inhaled budesonide (400 µg BD) or placebo
Medicin: comparison of treatment effect on different markers
inhaled budesonide (400 µg BD) or placebo BD
Andre navne:
  • Budesonid

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in inflammatory cell numbers and inflammatory markers at 3 months
Tidsramme: 3 months
inflammatory cell numbers and inflammatory markers (cytokines, chemokines, etc.) in different tissue compartments (induced sputum, BAL, bronchial biopsies, blood) will be measured at baseline and 3 months after treatment with budesonide and compared with those from healthy subjects
3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
network analysis of quantitative proteomics of bronchial biopsies
Tidsramme: 3 months
pathways analysis will be performed on proteins obtained from bronchial biopsies from asthmatics and COPD patients at baseline and 3 months after treatment
3 months
change of lung function, exNO after 3 months of treatment
Tidsramme: 3 months
lung function measurements (spirometry, bronchial responsiveness measurement, capsaicin test) at baseline and 3 months after treatment with budesonide
3 months

Samarbejdspartnere og efterforskere

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

Sponsor

Lithuanian University of Health Sciences

Samarbejdspartnere

Göteborg University

Efterforskere

  • Ledende efterforsker: Raimundas Sakalauskas, Prof., Kaunas University of Medicine

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.

Generelle publikationer

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. juni 2004

Primær færdiggørelse (Faktiske)

1. december 2006

Studieafslutning (Faktiske)

1. juni 2009

Datoer for studieregistrering

Først indsendt

31. maj 2011

Først indsendt, der opfyldte QC-kriterier

20. juni 2011

Først opslået (Skøn)

22. juni 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. april 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. april 2012

Sidst verificeret

1. april 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 48/2004

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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 comparison of treatment effect on different markers

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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CROs in Taiwan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner