Modification of Chronic Inflammation by Inhaled Carbon Monoxide in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether carbon monoxide is effective in the treatment of stable COPD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groningen Research Institute for Asthma and COPD
• Collaborator: Stichting Astma Bestrijding, The Netherlands
• Treatments: Carbon Monoxide

Criteria

Inclusion Criteria:

• Men and women, age > 40 years. Women must be post-menopausal (i.e. at least one year must have passed after the last menstruation), surgically sterile or using acceptable contraceptives, as judged by the investigator.

• A diagnosis of COPD according to the criteria of the American Thoracic Society (ATS); a disease state characterised by the presence of chronic airway obstruction due to chronic bronchitis (cough/sputum on most days a week for 3 months a year for at least two successive years); or emphysema.

• FEV1 > 0.7 litres

• FEV1/FVC ratio < 70% (equation retrieval system [ERS] equations)

• A smoking history of > 10 pack years

• Completely stopped smoking > 1 year ago

• No upper or lower respiratory tract infection in the last 4 weeks

• In a stable phase of COPD, as judged by the investigator

• Signed and dated informed consent obtained before any study related procedures (including withdrawal of concomitant medication) are conducted

Exclusion Criteria:

• Treatment with immune-modulating agents for any other disease

• History of asthma; former diagnosis of asthma

• Arterial oxygen tension (PaO2) < 8.0 kPa

• Any significant other pulmonary disease or disorder (e.g. alpha1-antitrypsin deficiency, bronchiectasies), as judged by the investigator

• Patients with other significant disease or disorder (like cardiovascular, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic [including diagnosed diabetes], malignant, psychiatric, major physical impairment), which, in the opinion of the investigator may either put the patient at risk because of participation in the study; or may influence the results of the study, or the patient's ability to participate in the study.

• Patients unable to blow reproducable lung function measurements

• Patients using medicine with anti-oxidant character like n-acetyl-cysteine.