Systemic Consequences and Comorbidities in Mild/Moderate Chronic Obstructive Pulmonary Disease (COPD), Time for Action!
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Purpose
The aim of this prospective case-control study is to investigate the prevalence, severity and incidence of systemic consequences in newly detected patients with mild and moderate Chronic obstructive pulmonary disease (COPD). Special attention will be paid to skeletal muscle dysfunction and physical inactivity as these factors are, together with smoking, potentially modifiable.
| Condition |
|---|
|
Chronic Obstructive Pulmonary Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Systemic Consequences and Comorbidities in Mild/Moderate COPD, Time for Action! |
- Prevalence of risk factors to develop comorbidities (vascular dysfunction, osteoporosis, muscle wasting and metabolic syndrome) [ Time Frame: baseline ] [ Designated as safety issue: No ]Common risk factors: smoking, copd, physical inactivity (steps (per day)and moderate intense PA (min/day)and systemic inflammation (CRP, fibrinogen, IL-6, IL-8, TNF-alpha). Specific risk factors: vascular (atherosclerosis (mean IMT carotid arteries), arterial stenosis (ankle brachial index) and arterial stiffness (brachial ankle pulse wave velocity)), bone (osteopenia: T-score < -1 at lumbar spine/femoral neck/total femur), muscle(fatfree mass index < 15/16(female/male) and respiratory/peripheral muscle weakness; < 80%predicted), metabolic (syndrome): definition by AHA
- Incidence and worsening of risk factors to develop comorbidities (vascular dysfunction, osteoporosis, muscle wasting and metabolic syndrome) [ Time Frame: 3 years ] [ Designated as safety issue: No ]Common risk factors: smoking, copd, physical inactivity (steps (per day)and moderate intense PA (min/day)and systemic inflammation (CRP, fibrinogen, IL-6, IL-8, TNF-alpha). Specific risk factors: vascular (atherosclerosis (mean IMT carotid arteries), arterial stenosis (ankle brachial index) and arterial stiffness (brachial ankle pulse wave velocity)), bone (osteopenia: T-score < -1 at lumbar spine/femoral neck/total femur), muscle(fatfree mass index < 15/16(female/male) and respiratory/peripheral muscle weakness; < 80%predicted), metabolic (syndrome): definition by AHA
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2009 |
| Groups/Cohorts |
|---|
|
patients with COPD
patients who were defined as COPD, based on post-bronchodilator spirometry (GOLD criteria). Patients will have at least 10 pack years
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smoking controls
patients with at least 10 pack years who have no COPD (based on post-bronchodilator spirometry)
|
|
non-smoking controls
patients with < 1 pack year who have no COPD (based on post-bronchodilator spirometry)
|
Detailed Description:
Three groups will be included in this study:
- Patients with COPD (cases)
- Patients with smoking history but no COPD (smoking controls)
- Patients with no smoking history and no COPD (non-smoking controls)
An extensive test battery will be performed at baseline and after 3 years:
Clinical assessment (height, weight and blood pressure)*
Complete pulmonary function ((post-bronchodilator)spirometry + diffusion)*
Sputum Induction
Fasting venous blood sample (fasting glucose, cholesterol, triglycerides, inflammatory markers, creatinine, NT pro BNP, hemoglobin, testosterone, vitamin D)
Vascular screening (arterial stiffness - arterial stenosis - CIMT)
Muscle force (peripheral + respiratory)*
Functional exercise capacity (6 MWT)**
Maximal exercise capacity (incremental cycle test)**
Dexa scan (osteoporosis - body composition)
Spiral CT scan of the chest
RX thorax - RX lumbar
Questionnaires (MRC, CCQ, SF-36, EQ5D, HADS, Exacerbation, CATZ)**
Physical activity monitoring (sensewear armband)*
* test will be repeated every 6 months
** test will be repeated every year
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Population-based sample from the general population: random selected patients from the environment of Leuven (Nelson Study), and co-workers from the University Hospital of Leuven
Inclusion Criteria:
- age 40-80 years old
cases: spirometry (post-bronchodilator) based diagnosis of COPD (GOLD criteria) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment.
smoking controls: no COPD (spirometry based) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment.
non-smoking controls: no COPD (spirometry based) + < 1 pack year
Exclusion Criteria:
- Respiratory disorder other than COPD
- α1-antitrypsine deficiency
- Known history of significant inflammatory disease other than COPD
- COPD exacerbation within 4 weeks prior to study
- Lung surgery
- Recent diagnosis of cancer
- Therapy with oral corticosteroids in the last 6 weeks
- Significant cardiovascular comorbidity
- Significant orthopedic/musculoskeletal problems
Contacts and Locations| Contact: Wim Janssens, Prof | +3216346800 | wim.janssens@med.kuleuven.be |
| Contact: Thierry Troosters, Prof | +3216347107 | thierry.troosters@med.kuleuven.be |
| Belgium | |
| University Hospital Leuven | Recruiting |
| Leuven, Belgium, 3000 | |
| Contact: Wim Janssens, Prof +3216341811 wim.janssens@med.kuleuven.be | |
| Contact: Thierry Troosters, Prof +3216341811 thierry.troosters@med.kuleuven.be | |
| Principal Investigator: Wim Janssens, MD, Phd | |
| Principal Investigator: Thierry Troosters, Phd | |
| Sub-Investigator: Marc Decramer, MD, Phd | |
| Sub-Investigator: Peter Verhamme, MD, Phd | |
| Sub-Investigator: Steven Boonen, MD, Phd | |
| Principal Investigator: | Wim Janssens, Prof | Katholieke Universiteit Leuven |
| Principal Investigator: | Thierry Troosters, Prof | Katholieke Universiteit Leuven |
More Information
No publications provided
| Responsible Party: | Prof Dr. W. Janssens, Katholieke Universiteit Leuven |
| ClinicalTrials.gov Identifier: | NCT01314807 History of Changes |
| Other Study ID Numbers: | The Rainbow study |
| Study First Received: | March 9, 2011 |
| Last Updated: | March 14, 2011 |
| Health Authority: | Belgium: Ethics Committee |
Keywords provided by Katholieke Universiteit Leuven:
|
COPD |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 18, 2013