Pathogenetic Mechanisms of Chronic Obstructive Pulmonary Diseases

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lithuanian University of Health Sciences
• Collaborator: Göteborg University
• Treatments: Budesonide

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.