Pulmonary Disease, Chronic ObstructivePhase 2NCT00122694
Modification of Chronic Inflammation by Inhaled Carbon Monoxide in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing carbon monoxide in people with Pulmonary Disease, Chronic Obstructive, run by Groningen Research Institute for Asthma and COPD at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether carbon monoxide is effective in the treatment of stable COPD. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- carbon monoxide
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2005to Mar 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Groningen, Department of Pulmonary Diseases
Groningen, Provincie Groningen, 9700RB
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- carbon monoxide
- Keywords
- carbon monoxide, COPD, inflammation, sputum induction, stable COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbon monoxideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startJan 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Groningen Research Institute for Asthma and COPD
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting Astma Bestrijding, The Netherlands
- Investigators
- H AM Kerstjens, Prof., MD, PhD, Principal investigator, University Medical Center Groningen, Department of Pulmonary Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122694
- Sponsor's protocol ID
- METc2003.249
- Other IDs
- SAB 2004/024
- Status last verified
- Jul 2006
- First submitted
- 21 Jul 2005
- Last updated
- 12 Sep 2006
- Results posted
- No
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. doi: 10.1183/09031936.00163206. Epub 2007 Aug 22.
PubMed 17715164
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification of Chronic Inflammation by Inhaled Carbon Monoxide in Patients With Stable COPD
- ClinicalTrials.gov ID
- NCT00122694
- Acronym / sponsor ID
- METc2003.249
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- carbon monoxide, COPD, inflammation, sputum induction, stable COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Groningen Research Institute for Asthma and COPDUniversity, hospital or other
- Collaborators
- Stichting Astma Bestrijding, The Netherlands
- Study start
- Jan 2005
- Study completion
- Mar 2006
- First posted
- 22 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carbon monoxide | Drug | – |
Primary outcome
percentage of neutrophils in induced sputum
5 secondary outcomes
methacholine provocation threshold
exhaled CO/NO
FEV1, FVC, RAW, sgaw
inflammatory parameters in sputum and blood
8-isoprostane in exhaled breath
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2006.
- Derived from this study: PubMed 17715164Bathoorn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H AM Kerstjens, Prof., MD, PhD principal investigator
University Medical Center Groningen, Department of Pulmonary Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carbon monoxide in people with Pulmonary Disease, Chronic Obstructive, run by Groningen Research Institute for Asthma and COPD at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of neutrophils in induced sputum. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00122694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2006.