Chronic Obstructive Pulmonary DiseaseNCT00864994
Multiorgan Pathology in Chronic Obstructive Pulmonary Disease (COPD)
An observational study of Chronic Obstructive Pulmonary Disease, run by Top Institute Pharma at 1 site in Netherlands.
Trial summary
There is increasing evidence in the literature that COPD should not be considered as a localised pulmonary disorder but as a systemic disease involving pathology in several extra pulmonary tissues. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2010to Apr 2015
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Totally 60 subjects will be included * 30 healthy subjects with 20 pack years smoking who have no signs of COPD (age 40-75 years) * 30 COPD patients with GOLD stage II (age 40-75 years)
Who may be able to join
- Age 40-75 years
- Age, pack years, FEV1/FVC and FEV1% predicted must fit in one of 2 groups of table 4.3
- Physically and mentally able to undergo the total study protocol
- Written informed consent
Who cannot join
- Participation in another study
- Alpha-1-antitrypsin deficiency
- Selected grade 1-3 co-morbidity listed in the ACE-27
- Active pulmonary infection like tuberculosis, pneumonia, flue, tracheobronchitis
- Active extra-pulmonary infection like hepatitis A-C, cystitis, gastroenteritis etc.
- Pulmonary diseases like sarcoidosis, IPF, silicosis, hypersensitivity pneumonitis, asthma
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- Life threatening diseases like carcinoma, AIDS (including HIV+), acute leukemia etc.
- Medication that may affect the results of the study: NSAID's, immunosuppressive agents like prednisolon, methotrexate, azathioprine, sintrom tablets, askal
- Antibiotic or prednisolon use in the past 2 months
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center, Dept. of Respiratory Medicine
Maastricht, Limburg, 6200 MD
Annemie Schols, Prof. dr. ir., +31 43 387 50 46, a.schols@pul.unimaas.nl
Emiel Wouters, Prof. dr. MD
About this study
Official title: COPD: Transition of Systemic Inflammation Into Multiorgan Pathology (Study 3). (De Effecten Van Ontsteking op Skeletspieren Bij COPD)
There is increasing evidence in the literature that COPD should not be considered as a localised pulmonary disorder but as a systemic disease involving pathology in several extra pulmonary tissues. Well characterized systemic features are a chronic low grade systemic inflammation, altered body composition and a skeletal muscle fibre type shift. There are indications that an absolute or relative increase of fat mass puts COPD patients at increased risk for cardiovascular pathology while muscle atrophy is associated with a high prevalence of osteoporosis and with impaired physical function. The origin of systemic inflammation is poorly understood. Both endogenous and exogenous risk factors contribute to systemic inflammation and extra-pulmonary manifestations of COPD.
Overall objective of study 3:
Read more
To compare the pattern and severity of the systemic inflammatory profile in relation to skeletal muscle weakness and cardiovascular risk profile in COPD patients with mild to moderate disease compared to non-susceptible smokers.
Specific objectives:
- To study the relative contribution of pulmonary and extra pulmonary factors on exercise capacity, skeletal muscle function and health status
- To relate diet, physical activity and cardiovascular risk factors to body composition, skeletal muscle function and exercise capacity status
- To study the influence of the emphysema phenotype on extra pulmonary pathology in COPD
- To study muscle fibre type size and composition and to relate muscle oxidative phenotype with insulin sensitivity, inflammation (local and systemic) and molecular signatures of oxidative energy and protein metabolism.
Study design:
Cross-sectional study. Healthy smoking subjects and COPD patients will undergo extensive clinical, metabolic and inflammatory assessment at the university clinics in Groningen, Maastricht and CIRO Horn.
Study population:
Totally 60 subjects will be included
- 30 healthy subjects who after 20 pack years smoking have no signs of COPD (age 40-75 years)
- 30 COPD patients with GOLD stage II (age 40-75 years)
Read the detailed description
Primary study parameters/outcome of the study:
- Smoking history and behaviour, diet and physical activity level assessed by questionnaire
- Extensive lung function and CT scanning of the lung, ECG
- Candidate genes for muscle dysfunction and CVD risk
- Body composition (BIA, waist-hip ratio, DEXA-scan)
- Systemic inflammation
- Advanced Glycosylated Endproduct (AGE)
- Glucose tolerance test
- Risk factors of metabolic syndrome
- 6 minute walking distance
- Handgrip strength
- Skeletal muscle function by isokinetic dynamometry
- Physical activity level and pattern by accelerometry
- Muscle oxidative phenotype, fibre cross-sectional area and molecular signatures obtained in vastus lateralis muscle biopsies before and after incremental cycle ergometry
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
- Totally 22 hours will be spend in the hospital during 3 visits
- CT-scanning of the lung is associated with a radiation burden of 0.8-1.6 mSv (dependent of body weight)
- 50 ml peripheral blood (v. cubiti)
- Muscle biopsy may be associated with temporary pain and haematoma
- Drawing of arterial blood from the radial artery rarely leads to bleeding and transitory nerve damage (numb feeling in wrist/hand area).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Inflammation, Smoking, Multiorgan pathology, Extra pulmonary manifestations
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Inflammation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | • 30 healthy subjects with 20 pack years smoking who have no signs of COPD (age 40-75 years) | |
| 2 | • 30 COPD patients with GOLD stage II (age 40-75 years) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking history and behaviour, diet and physical activity level assessed by questionnaire
Extensive lung function and CT scanning of the lung, ECG
Candidate genes for muscle dysfunction and CVD risk
Body composition
Systemic inflammation
Advanced Glycosylated Endproduct (AGE)
Glucose Tolerance Test
Risk factors of metabolic syndrome
6 minutes walking distance
Handgrip strength
Skeletal muscle function by isokinetic dynamometry
Physical activity level and pattern by accelerometry
Muscle oxidative phenotype, fibre cross-sectional area and molecular signatures obtained in vastus lateralis muscle biopsies before and after incremental cycle ergometry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startSep 2010
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Top Institute Pharma
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen, Maastricht University Medical Center, UMC Utrecht, Danone Institute International, GlaxoSmithKline, Nycomed, AstraZeneca
- Investigators
- Emiel Wouters, Prof. dr. MD, Principal investigator, Maastricht University Medical Center, Dept. of Respiratory Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864994
- Sponsor's protocol ID
- 23475
- Status last verified
- Sep 2010
- First submitted
- 18 Mar 2009
- Last updated
- 29 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPD: Transition of Systemic Inflammation Into Multiorgan Pathology (Study 3). (De Effecten Van Ontsteking op Skeletspieren Bij COPD)
- ClinicalTrials.gov ID
- NCT00864994
- Acronym / sponsor ID
- 23475
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Inflammation, Smoking, Multiorgan pathology, Extra pulmonary manifestations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Top Institute PharmaUniversity, hospital or other
- Collaborators
- University Medical Center Groningen, Maastricht University Medical Center, UMC Utrecht, Danone Institute International, GlaxoSmithKline, Nycomed, AstraZeneca
- Study start
- Sep 2010
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 19 Mar 2009 (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.
There is increasing evidence in the literature that COPD should not be considered as a localised pulmonary disorder but as a systemic disease involving pathology in several extra pulmonary tissues. Well characterized systemic features are a chronic low grade systemic inflammation, altered body composition and a skeletal muscle fibre type shift. There are indications that an absolute or relative increase of fat mass puts COPD patients at increased risk for cardiovascular pathology while muscle atrophy is associated with a high prevalence of osteoporosis and with impaired physical function. The origin of systemic inflammation is poorly understood. Both endogenous and exogenous risk factors contribute to systemic inflammation and extra-pulmonary manifestations of COPD.
Overall objective of study 3:
To compare the pattern and severity of the systemic inflammatory profile in relation to skeletal muscle weakness and cardiovascular risk profile in COPD patients with mild to moderate disease compared to non-susceptible smokers.
Specific objectives:
- To study the relative contribution of pulmonary and extra pulmonary factors on exercise capacity, skeletal muscle function and health status
- To relate diet, physical activity and cardiovascular risk factors to body composition, skeletal muscle function and exercise capacity status
- To study the influence of the emphysema phenotype on extra pulmonary pathology in COPD
- To study muscle fibre type size and composition and to relate muscle oxidative phenotype with insulin sensitivity, inflammation (local and systemic) and molecular signatures of oxidative energy and protein metabolism.
Study design:
Cross-sectional study. Healthy smoking subjects and COPD patients will undergo extensive clinical, metabolic and inflammatory assessment at the university clinics in Groningen, Maastricht and CIRO Horn.
Study population:
Totally 60 subjects will be included
- 30 healthy subjects who after 20 pack years smoking have no signs of COPD (age 40-75 years)
- 30 COPD patients with GOLD stage II (age 40-75 years)
Detailed description
Primary study parameters/outcome of the study:
- Smoking history and behaviour, diet and physical activity level assessed by questionnaire
- Extensive lung function and CT scanning of the lung, ECG
- Candidate genes for muscle dysfunction and CVD risk
- Body composition (BIA, waist-hip ratio, DEXA-scan)
- Systemic inflammation
- Advanced Glycosylated Endproduct (AGE)
- Glucose tolerance test
- Risk factors of metabolic syndrome
- 6 minute walking distance
- Handgrip strength
- Skeletal muscle function by isokinetic dynamometry
- Physical activity level and pattern by accelerometry
- Muscle oxidative phenotype, fibre cross-sectional area and molecular signatures obtained in vastus lateralis muscle biopsies before and after incremental cycle ergometry
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
- Totally 22 hours will be spend in the hospital during 3 visits
- CT-scanning of the lung is associated with a radiation burden of 0.8-1.6 mSv (dependent of body weight)
- 50 ml peripheral blood (v. cubiti)
- Muscle biopsy may be associated with temporary pain and haematoma
- Drawing of arterial blood from the radial artery rarely leads to bleeding and transitory nerve damage (numb feeling in wrist/hand area).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –• 30 healthy subjects with 20 pack years smoking who have no signs of COPD (age 40-75 years) |
| 2 | – | –• 30 COPD patients with GOLD stage II (age 40-75 years) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Totally 60 subjects will be included * 30 healthy subjects with 20 pack years smoking who have no signs of COPD (age 40-75 years) * 30 COPD patients with GOLD stage II (age 40-75 years)
Key inclusion criteria (4 listed)
- Age 40-75 years
- Age, pack years, FEV1/FVC and FEV1% predicted must fit in one of 2 groups of table 4.3
- Physically and mentally able to undergo the total study protocol
- Written informed consent
Key exclusion criteria (9 listed)
- Participation in another study
- Alpha-1-antitrypsin deficiency
- Selected grade 1-3 co-morbidity listed in the ACE-27
- Active pulmonary infection like tuberculosis, pneumonia, flue, tracheobronchitis
- Active extra-pulmonary infection like hepatitis A-C, cystitis, gastroenteritis etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Smoking history and behaviour, diet and physical activity level assessed by questionnaire
Extensive lung function and CT scanning of the lung, ECG
Candidate genes for muscle dysfunction and CVD risk
Body composition
Systemic inflammation
Advanced Glycosylated Endproduct (AGE)
Glucose Tolerance Test
Risk factors of metabolic syndrome
6 minutes walking distance
Handgrip strength
Skeletal muscle function by isokinetic dynamometry
Physical activity level and pattern by accelerometry
Muscle oxidative phenotype, fibre cross-sectional area and molecular signatures obtained in vastus lateralis muscle biopsies before and after incremental cycle ergometry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2010.
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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.
Emiel Wouters, Prof. dr. MD principal investigator
Maastricht University Medical Center, Dept. of Respiratory Medicine
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 Top Institute Pharma 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 29 Mar 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AMWJ Schols, Prof. dr. ir. (+31 43 387 5046, a.schols@pul.unimaas.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking history and behaviour, diet and physical activity level assessed by questionnaire. The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 29 Mar 2010.