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

This study has been completed.
Sponsor:
Collaborator:
Stichting Astma Bestrijding, The Netherlands
Information provided by:
Groningen Research Institute for Asthma and COPD
ClinicalTrials.gov Identifier:
NCT00122694
First received: July 21, 2005
Last updated: September 11, 2006
Last verified: July 2006
  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 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Carbon Monoxide
Antimetabolites
Gasotransmitters
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014