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

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ClinicalTrials.gov Identifier: NCT00122694
Recruitment Status : Completed
First Posted : July 22, 2005
Last Update Posted : September 12, 2006
Sponsor:
Collaborator:
Stichting Astma Bestrijding, The Netherlands
Information provided by:
Groningen Research Institute for Asthma and COPD

Study Description
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Brief Summary:
The purpose of this study is to determine whether carbon monoxide is effective in the treatment of stable COPD.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: carbon monoxide Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Modification of Chronic Inflammation by Inhaled Carbon Monoxide in Patients With Stable COPD
Study Start Date : January 2005
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. percentage of neutrophils in induced sputum

Secondary Outcome Measures :
  1. methacholine provocation threshold
  2. exhaled CO/NO
  3. FEV1, FVC, RAW, sgaw
  4. inflammatory parameters in sputum and blood
  5. 8-isoprostane in exhaled breath

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00122694


Locations
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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
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Principal Investigator: H AM Kerstjens, Prof., MD, PhD University Medical Center Groningen, Department of Pulmonary Diseases
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00122694    
Other Study ID Numbers: METc2003.249
SAB 2004/024
First Posted: July 22, 2005    Key Record Dates
Last Update Posted: September 12, 2006
Last Verified: July 2006
Keywords provided by Groningen Research Institute for Asthma and COPD:
carbon monoxide
COPD
inflammation
sputum induction
stable COPD
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Inflammation
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive
 Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs