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

This study has been completed.

First Received on July 21, 2005. Last Updated on September 11, 2006 History of Changes

Sponsor:	Groningen Research Institute for Asthma and COPD
Collaborator:	Stichting Astma Bestrijding, The Netherlands
Information provided by:	Groningen Research Institute for Asthma and COPD
ClinicalTrials.gov Identifier:	NCT00122694

Purpose

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

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Drug: carbon monoxide	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Modification of Chronic Inflammation by Inhaled Carbon Monoxide in Patients With Stable COPD

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Carbon monoxide

U.S. FDA Resources

Further study details as provided by Groningen Research Institute for Asthma and COPD:

Primary Outcome Measures:

percentage of neutrophils in induced sputum

Secondary Outcome Measures:

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

Estimated Enrollment:	20
Study Start Date:	January 2005
Estimated Study Completion Date:	March 2006

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.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122694

Locations

Netherlands
University Medical Center Groningen, Department of Pulmonary Diseases
Groningen, Netherlands, 9700RB

Sponsors and Collaborators

Groningen Research Institute for Asthma and COPD

Stichting Astma Bestrijding, The Netherlands

Investigators

Principal Investigator:

H AM Kerstjens, Prof., MD, PhD

University Medical Center Groningen, Department of Pulmonary Diseases

More Information

No publications provided by Groningen Research Institute for Asthma and COPD

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bathoorn E, Slebos DJ, Postma DS, Koeter GH, van Oosterhout AJ, van der Toorn M, Boezen HM, Kerstjens HA. Anti-inflammatory effects of inhaled carbon monoxide in patients with COPD: a pilot study. Eur Respir J. 2007 Dec;30(6):1131-7. Epub 2007 Aug 22.

ClinicalTrials.gov Identifier:	NCT00122694 History of Changes
Other Study ID Numbers:	METc2003.249, SAB 2004/024
Study First Received:	July 21, 2005
Last Updated:	September 11, 2006
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Groningen Research Institute for Asthma and COPD:

carbon monoxide
COPD
inflammation
sputum induction
stable COPD

Additional relevant MeSH terms:

Chronic Disease
Inflammation
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes

Pathologic Processes
Respiratory Tract Diseases
Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012