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Pathogenetic Mechanisms of Chronic Obstructive Pulmonary Diseases (CAPTA)

11 april 2012 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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

Studietyp

Interventionell

Inskrivning (Faktisk)

200

Fas

  • Inte tillämpbar

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

30 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: Budesonide
patients who gave their agreement were randomised to 3 months treatment with either inhaled budesonide (400 µg BD) or placebo
Läkemedel: comparison of treatment effect on different markers
inhaled budesonide (400 µg BD) or placebo BD
Andra namn:
  • Budesonid

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from Baseline in inflammatory cell numbers and inflammatory markers at 3 months
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
network analysis of quantitative proteomics of bronchial biopsies
Tidsram: 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
Tidsram: 3 months
lung function measurements (spirometry, bronchial responsiveness measurement, capsaicin test) at baseline and 3 months after treatment with budesonide
3 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Lithuanian University of Health Sciences

Samarbetspartners

Göteborg University

Utredare

  • Huvudutredare: Raimundas Sakalauskas, Prof., Kaunas University of Medicine

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.

Allmänna publikationer

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 juni 2004

Primärt slutförande (Faktisk)

1 december 2006

Avslutad studie (Faktisk)

1 juni 2009

Studieregistreringsdatum

Först inskickad

31 maj 2011

Först inskickad som uppfyllde QC-kriterierna

20 juni 2011

Första postat (Uppskatta)

22 juni 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

12 april 2012

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 april 2012

Senast verifierad

1 april 2012

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 48/2004

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

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