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

Phase 2

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT00122694
• Lead Sponsor: Groningen Research Institute for Asthma and COPD

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 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.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-07-21
• Study First Submitted QC: 2005-07-21
• Study First Posted: 2005-07-22
• Study Completion: 2006-03
• Status Verified: 2006-07
• Last Update Submitted: 2006-09-11
• Last Update Posted: 2006-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
percentage of neutrophils in induced sputum

Secondary Outcome Measures

Name	Time	Method
FEV1, FVC, RAW, sgaw
methacholine provocation threshold
exhaled CO/NO
inflammatory parameters in sputum and blood
8-isoprostane in exhaled breath

Trial Locations

Locations (1)

University Medical Center Groningen, Department of Pulmonary Diseases; 🇳🇱 Groningen, Netherlands