Pathogenetic Mechanisms of Chronic Obstructive Pulmonary Diseases — CAPTA  

Asthma Clinical Trial

Official title: Evaluation of Pathogenetic Mechanisms of Chronic Obstructive Pulmonary Diseases

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Asthma
• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

• NCT number: NCT01378039
• Study type: Interventional
• Source: Lithuanian University of Health Sciences
• Status: Completed
• Phase: N/A
• Start date: June 2004
• Completion date: June 2009