Pathogenetic Mechanisms of Chronic Obstructive Pulmonary Diseases

NCT01378039 | Completed

• 1 other identifier: 48/2004
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COPD; Asthma

Keywords

COPD; Asthma; Pathophysiology; Genetics; Phenotype; Treatment response

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in inflammatory cell numbers and inflammatory markers at 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

Secondary Outcomes (2)

• network analysis of quantitative proteomics of bronchial biopsies

  3 months

• change of lung function, exNO after 3 months of treatment

  3 months

Study Arms (1)

Budesonide

OTHER

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

Interventions

comparison of treatment effect on different markers DRUG

inhaled budesonide (400 µg BD) or placebo BD

Also known as: Budesonide

Budesonide

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead
• Göteborg University: collaborator

Related Publications (1)

• O'Neil SE, Sitkauskiene B, Babusyte A, Krisiukeniene A, Stravinskaite-Bieksiene K, Sakalauskas R, Sihlbom C, Ekerljung L, Carlsohn E, Lotvall J. Network analysis of quantitative proteomics on asthmatic bronchi: effects of inhaled glucocorticoid treatment. Respir Res. 2011 Sep 22;12(1):124. doi: 10.1186/1465-9921-12-124.

  PMID: 21939520 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Raimundas Sakalauskas, Prof.

  Kaunas University of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 22, 2011
• Study Start: June 1, 2004
• Primary Completion: December 1, 2006
• Study Completion: June 1, 2009
• Last Updated: April 12, 2012

Record last verified: 2012-04