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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

Tracking Information
First Submitted Date  ICMJE July 21, 2005
First Posted Date  ICMJE July 22, 2005
Last Update Posted Date September 12, 2006
Study Start Date  ICMJE January 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2005)
percentage of neutrophils in induced sputum
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2005)
 neutrophils in induced sputum.
Change History Complete list of historical versions of study NCT00122694 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2005)
  • methacholine provocation threshold
  • exhaled CO/NO
  • FEV1, FVC, RAW, sgaw
  • inflammatory parameters in sputum and blood
  • 8-isoprostane in exhaled breath
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2005)
  • metacholine provocation treshold
  • exhaled CO/NO
  • FEV1, FVC, RAW, sgaw
  • inflammatory parameters in sputum and blood
  • 8-isoprostane in exhaled breath
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Modification of Chronic Inflammation by Inhaled Carbon Monoxide in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD)
Official Title  ICMJE Modification of Chronic Inflammation by Inhaled Carbon Monoxide in Patients With Stable 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE Drug: carbon monoxide
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: July 21, 2005)
20
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE March 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00122694
Other Study ID Numbers  ICMJE METc2003.249
SAB 2004/024
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Groningen Research Institute for Asthma and COPD
Collaborators  ICMJE Stichting Astma Bestrijding, The Netherlands
Investigators  ICMJE
Principal Investigator: H AM Kerstjens, Prof., MD, PhD University Medical Center Groningen, Department of Pulmonary Diseases
PRS Account Groningen Research Institute for Asthma and COPD
Verification Date July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP