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

NCT00122694 | Completed Phase 2

• 2 other identifiers: METc2003.249SAB 2004/024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

carbon monoxide; COPD; inflammation; sputum induction; stable COPD

Outcome Measures

Primary Outcomes (1)

• percentage of neutrophils in induced sputum

Secondary Outcomes (5)

• methacholine provocation threshold

• exhaled CO/NO

• FEV1, FVC, RAW, sgaw

• inflammatory parameters in sputum and blood

• 8-isoprostane in exhaled breath

Interventions

carbon monoxide DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Groningen Research Institute for Asthma and COPD: lead
• Stichting Astma Bestrijding, The Netherlands: collaborator

Study Sites (1)

University Medical Center Groningen, Department of Pulmonary Diseases

Groningen, Provincie Groningen, 9700RB, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 17715164 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Inflammation

Interventions

Carbon Monoxide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbon Compounds, Inorganic; Inorganic Chemicals; Gases; Oxides; Oxygen Compounds

Study Officials

• H AM Kerstjens, Prof., MD, PhD

  University Medical Center Groningen, Department of Pulmonary Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 21, 2005
• First Posted: July 22, 2005
• Study Start: January 1, 2005
• Study Completion: March 1, 2006
• Last Updated: September 12, 2006

Record last verified: 2006-07

Locations

NL (1)