Status:
COMPLETED
Modification of Chronic Inflammation by Inhaled Carbon Monoxide in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Groningen Research Institute for Asthma and COPD
Collaborating Sponsors:
Stichting Astma Bestrijding, The Netherlands
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether carbon monoxide is effective in the treatment of stable COPD.
Detailed Description
COPD is characterised by a chronic pulmonary inflammation and a shifted oxidant/antioxidant balance. The main cause of this inflammation is smoking. After smoking cessation, this inflammation and shif...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00122694
Start Date
January 1 2005
End Date
March 1 2006
Last Update
September 12 2006
Active Locations (1)
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1
University Medical Center Groningen, Department of Pulmonary Diseases
Groningen, Provincie Groningen, Netherlands, 9700RB