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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
carbon monoxide
Sponsored by
Groningen Research Institute for Asthma and COPD
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring carbon monoxide, COPD, inflammation, sputum induction, stable COPD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Medical Center Groningen, Department of Pulmonary Diseases

Outcomes

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

Full Information

First Posted
July 21, 2005
Last Updated
September 11, 2006
Sponsor
Groningen Research Institute for Asthma and COPD
Collaborators
Stichting Astma Bestrijding, The Netherlands
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1. Study Identification

Unique Protocol Identification Number
NCT00122694
Brief Title
Modification of Chronic Inflammation by Inhaled Carbon Monoxide in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD)
Official Title
Modification of Chronic Inflammation by Inhaled Carbon Monoxide in Patients With Stable COPD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Groningen Research Institute for Asthma and COPD
Collaborators
Stichting Astma Bestrijding, The Netherlands

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
carbon monoxide, COPD, inflammation, sputum induction, stable COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carbon monoxide
Primary Outcome Measure Information:
Title
percentage of neutrophils in induced sputum
Secondary Outcome Measure Information:
Title
methacholine provocation threshold
Title
exhaled CO/NO
Title
FEV1, FVC, RAW, sgaw
Title
inflammatory parameters in sputum and blood
Title
8-isoprostane in exhaled breath

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H AM Kerstjens, Prof., MD, PhD
Organizational Affiliation
University Medical Center Groningen, Department of Pulmonary Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen, Department of Pulmonary Diseases
City
Groningen
ZIP/Postal Code
9700RB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
17715164
Citation
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. doi: 10.1183/09031936.00163206. Epub 2007 Aug 22.
Results Reference
derived

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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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