Chronic Obstructive Pulmonary DiseaseNCT00452764
Regulatory T Cells in COPD
An observational study of Chronic Obstructive Pulmonary Disease, run by Groningen Research Institute for Asthma and COPD at 1 site in Netherlands.
Trial summary
Lymphoid follicles, consisting of T-and B cells, are involved in the chronic inflammatory response in COPD. Foxp3 positive regulatory T cells (Tregs) are present in these follicles and may be involved in the suppression of this chronic inflammatory response. Read more about this study
- Who is it for?
- Ages 40 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Withdrawal of medication
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2007to Nov 2007
- Phase
- Observational
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- COPD patients
- Clinical diagnosed COPD
- No allergies
- Post-bronchodilator FEV1 < 80% predicted, and post-bronchodilator FEV1/FVC < 70%
- No use of (inhaled) corticosteroids in the 6 weeks preceding the study
- Age > 40
Show all 19Show fewer
- Smokers and ex- smokers > 10 pack years
- Ex-smokers have to have quitted smoking for at least one year
- No other major current health problems
- Informed consent Healthy controls
- No signs of pulmonary disease
- No allergies or hyperreactivity
- No other major current health problems
- FEV1 > 90 % predicted, FEV1/FVC > 70%
- Age > 40
- Never smokers, i.e. no cigarettes last year, and maximal 5 pack years
- Smokers and ex- smokers > 10 pack years
- Ex-smokers have to have quitted smoking for at least one year
- Informed consent
Who cannot join
- Use of (inhaled) corticosteroids in the 6 weeks preceding the study
- Addiction to alcohol or drugs
- COPD exacerbation in the 6 weeks preceding the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phenotype and Number of Regulatory T Cells Present in Peripheral Blood of COPD Patients Versus Healthy Controls
Lymphoid follicles, consisting of T-and B cells, are involved in the chronic inflammatory response in COPD. Foxp3 positive regulatory T cells (Tregs) are present in these follicles and may be involved in the suppression of this chronic inflammatory response.
We hypothesise that a dysfunction of Tregs underlies the development of the inflammatory response in COPD. This could be either due to a decreased presence of Tregs in COPD, or to an altered function of Tregs possibly caused by a decreased HO-1 expression and/or an altered TGFβ regulation.
Read the detailed description
COPD is a leading cause of death worldwide and its morbidity and mortality are still rising.So far, no effective treatment is available To find better treatment methods more insight is needed in the nature/origin of the chronic inflammation that underlies the development of COPD.
The important role of neutrophils, macrophages and cytotoxic T cells is well established in this respect, yet the role of CD4 T cells and B cells has only recently (re)attracted attention. We detected the presence of lymphoid follicles in lung tissue of COPD patients, consisting of B cells surrounded by T cells. Recently, we have found the presence of Foxp3 positive T cells as a component of these lymphoid follicles in COPD. Since Foxp3 is a distinctive marker of regulatory T cells (Tregs), this finding suggests that Tregs are involved in the inflammatory response in COPD.
Tregs are important in controlling immunological tolerance and preventing auto-immune responses by inhibiting T-cell responses. Dysfunction of Tregs can lead to auto-immune diseases, allergy and chronic inflammatory diseases. However, nothing is known so far about their contribution to the chronic inflammatory response in COPD. Recent studies show that, next to direct inhibition by cell-cell contact, the inhibitory effects of Tregs are mediated by heme oxygenase-1 (HO-1) expression and membrane bound TGFβ.
We hypothesise that a dysfunction of regulatory T cells underlies the development of the inflammatory response in COPD. This could be due to a decreased presence of Tregs in COPD, or to an altered function of Tregs. The latter may be due to a decreased HO-1 expression, as we have shown in macrophages of COPD patients compared to those in healthy controls, and/or an altered TGFβ regulation, a cytokine that plays a prime role in COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Withdrawal of medication
- Keywords
- COPD, Healthy, Regulatory T cell, Heme oxygenase-1, peripheral blood
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Withdrawal of medicationBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2007 (estimated)
- Study startJan 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groningen Research Institute for Asthma and COPD
- Sponsor type
- University, hospital or other
- Investigators
- Huib AM Kerstjens, MD, PhD, Principal investigator, UMCG, department of pulmonary diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00452764
- Sponsor's protocol ID
- METc2006-135
- Status last verified
- Nov 2007
- First submitted
- 26 Mar 2007
- Last updated
- 8 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotype and Number of Regulatory T Cells Present in Peripheral Blood of COPD Patients Versus Healthy Controls
- ClinicalTrials.gov ID
- NCT00452764
- Acronym / sponsor ID
- METc2006-135
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Healthy, Regulatory T cell, Heme oxygenase-1, peripheral blood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Groningen Research Institute for Asthma and COPDUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Nov 2007 (actual)
- First posted
- 27 Mar 2007 (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.
Lymphoid follicles, consisting of T-and B cells, are involved in the chronic inflammatory response in COPD. Foxp3 positive regulatory T cells (Tregs) are present in these follicles and may be involved in the suppression of this chronic inflammatory response.
We hypothesise that a dysfunction of Tregs underlies the development of the inflammatory response in COPD. This could be either due to a decreased presence of Tregs in COPD, or to an altered function of Tregs possibly caused by a decreased HO-1 expression and/or an altered TGFβ regulation.
Detailed description
COPD is a leading cause of death worldwide and its morbidity and mortality are still rising.So far, no effective treatment is available To find better treatment methods more insight is needed in the nature/origin of the chronic inflammation that underlies the development of COPD.
The important role of neutrophils, macrophages and cytotoxic T cells is well established in this respect, yet the role of CD4 T cells and B cells has only recently (re)attracted attention. We detected the presence of lymphoid follicles in lung tissue of COPD patients, consisting of B cells surrounded by T cells. Recently, we have found the presence of Foxp3 positive T cells as a component of these lymphoid follicles in COPD. Since Foxp3 is a distinctive marker of regulatory T cells (Tregs), this finding suggests that Tregs are involved in the inflammatory response in COPD.
Tregs are important in controlling immunological tolerance and preventing auto-immune responses by inhibiting T-cell responses. Dysfunction of Tregs can lead to auto-immune diseases, allergy and chronic inflammatory diseases. However, nothing is known so far about their contribution to the chronic inflammatory response in COPD. Recent studies show that, next to direct inhibition by cell-cell contact, the inhibitory effects of Tregs are mediated by heme oxygenase-1 (HO-1) expression and membrane bound TGFβ.
We hypothesise that a dysfunction of regulatory T cells underlies the development of the inflammatory response in COPD. This could be due to a decreased presence of Tregs in COPD, or to an altered function of Tregs. The latter may be due to a decreased HO-1 expression, as we have shown in macrophages of COPD patients compared to those in healthy controls, and/or an altered TGFβ regulation, a cytokine that plays a prime role in COPD.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- COPD patients
- Clinical diagnosed COPD
- No allergies
- Post-bronchodilator FEV1 < 80% predicted, and post-bronchodilator FEV1/FVC < 70%
- No use of (inhaled) corticosteroids in the 6 weeks preceding the study
Key exclusion criteria (3 listed)
- Use of (inhaled) corticosteroids in the 6 weeks preceding the study
- Addiction to alcohol or drugs
- COPD exacerbation in the 6 weeks preceding 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 |
|---|---|---|
| Withdrawal of medication | Behavioural | – |
Primary outcome
Not reported in the source record.
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 8 Nov 2007.
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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.
Huib AM Kerstjens, MD, PhD principal investigator
UMCG, 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?
An observational study of Chronic Obstructive Pulmonary Disease, 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 19 inclusion and 3 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 8 Nov 2007. 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.
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.
Where can I read the original study information?
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 8 Nov 2007; AzTrials last refreshed its copy on 29 Oct 2026.