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Pathogenetic Mechanisms of Chronic Obstructive Pulmonary Diseases (CAPTA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01378039
Recruitment Status : Completed
First Posted : June 22, 2011
Last Update Posted : April 12, 2012
Sponsor:
Collaborator:
Göteborg University
Information provided by (Responsible Party):
Raimundas Sakalauskas, Lithuanian University of Health Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
COPD Asthma Drug: comparison of treatment effect on different markers Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Official Title: Evaluation of Pathogenetic Mechanisms of Chronic Obstructive Pulmonary Diseases
Study Start Date : June 2004
Actual Primary Completion Date : December 2006
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
Drug Information available for: Budesonide

Arm Intervention/treatment
Budesonide
patients who gave their agreement were randomised to 3 months treatment with either inhaled budesonide (400 µg BD) or placebo
Drug: comparison of treatment effect on different markers
inhaled budesonide (400 µg BD) or placebo BD
Other Name: Budesonide




Primary Outcome Measures :
  1. Change from Baseline in inflammatory cell numbers and inflammatory markers at 3 months [ Time Frame: 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


Secondary Outcome Measures :
  1. network analysis of quantitative proteomics of bronchial biopsies [ Time Frame: 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

  2. change of lung function, exNO after 3 months of treatment [ Time Frame: 3 months ]
    lung function measurements (spirometry, bronchial responsiveness measurement, capsaicin test) at baseline and 3 months after treatment with budesonide



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01378039


Sponsors and Collaborators
Lithuanian University of Health Sciences
Göteborg University
Investigators
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Principal Investigator: Raimundas Sakalauskas, Prof. Kaunas University of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Raimundas Sakalauskas, Professor, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier: NCT01378039    
Other Study ID Numbers: 48/2004
First Posted: June 22, 2011    Key Record Dates
Last Update Posted: April 12, 2012
Last Verified: April 2012
Keywords provided by Raimundas Sakalauskas, Lithuanian University of Health Sciences:
COPD
Asthma
Pathophysiology
Genetics
Phenotype
Treatment response
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists