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
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Tracking Information | ||||
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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 |
percentage of neutrophils in induced sputum | |||
Original Primary Outcome Measures ICMJE |
neutrophils in induced sputum. | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Primary Purpose: Treatment |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE |
20 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | March 2006 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |
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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 |