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

Groningen Research Institute for Asthma and COPD

Status and phase

Completed

Phase 2

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Drug: carbon monoxide

Study type

Interventional

Funder types

Other

Identifiers

NCT00122694

METc2003.249

SAB 2004/024

Details and patient eligibility

About

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

Full 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 shifted oxidant/antioxidant balance continues. This causes an increased deterioration of lung function compared to healthy persons of matching age.

The ongoing inflammation appears to be relatively insensitive to corticosteroid therapy.

Until now, there is no therapy for this inflammation. Both in vitro and in vivo studies show that carbon monoxide has, besides an antioxidant capacity, anti-inflammatory properties. The aim of this trial is to study whether the inflammation can be reduced by inhalation of carbon monoxide.

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.