NCT01378039

Pathogenetic Mechanisms of Chronic Obstructive Pulmonary Diseases

Evaluation of Pathogenetic Mechanisms of Chronic Obstructive Pulmonary Diseases

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Lithuanian University of Health Sciences · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

Conditions

• COPD
• Asthma

Interventions

Type	Name	Description
DRUG	comparison of treatment effect on different markers	inhaled budesonide (400 µg BD) or placebo BD

Timeline

• Start date: 2004-06-01
• Primary completion: 2006-12-01
• Completion: 2009-06-01
• First posted: 2011-06-22
• Last updated: 2012-04-12