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

September 11, 2006 updated by: Groningen Research Institute for Asthma and COPD

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
percentage of neutrophils in induced sputum

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groningen Research Institute for Asthma and COPD

Collaborators

Stichting Astma Bestrijding, The Netherlands

Investigators

  • Principal Investigator: H AM Kerstjens, Prof., MD, PhD, University Medical Center Groningen, Department of Pulmonary Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

July 21, 2005

First Submitted That Met QC Criteria

July 21, 2005

First Posted (Estimate)

July 22, 2005

Study Record Updates

Last Update Posted (Estimate)

September 12, 2006

Last Update Submitted That Met QC Criteria

September 11, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METc2003.249
  • SAB 2004/024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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