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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Modification of Chronic Inflammation by Inhaled Carbon Monoxide in Patients With Stable COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00122694
• Other study ID #: METc2003.249
• Secondary ID: SAB 2004/024
• Status: Completed
• Phase: Phase 2
• First received: July 21, 2005
• Last updated: September 11, 2006
• Start date: January 2005
• Est. completion date: March 2006

Study information

• Verified date: July 2006
• Source: Groningen Research Institute for Asthma and COPD
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Inflammation
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• carbon monoxide

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen, Department of Pulmonary Diseases	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
Groningen Research Institute for Asthma and COPD	Stichting Astma Bestrijding, The Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of neutrophils in induced sputum
Secondary	methacholine provocation threshold
Secondary	exhaled CO/NO
Secondary	FEV1, FVC, RAW, sgaw
Secondary	inflammatory parameters in sputum and blood
Secondary	8-isoprostane in exhaled breath