Chronic Obstructive Pulmonary DiseaseNCT01314807
Systemic Consequences and Comorbidities in Mild/Moderate Chronic Obstructive Pulmonary Disease (COPD), Time for Action!
An observational study of Chronic Obstructive Pulmonary Disease, run by KU Leuven at 1 site in Belgium.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2009to Jan 2018
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- Respiratory disorder other than COPD
- α1-antitrypsin deficiency
- Known history of significant inflammatory disease other than COPD
- COPD exacerbation within 4 weeks prior to study
- Lung surgery
- Recent diagnosis of cancer
Show all 9Show fewer
- Therapy with oral corticosteroids in the last 6 weeks
- Significant cardiovascular comorbidity
- Significant orthopedic/musculoskeletal problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systemic Consequences and Comorbidities in Mild/Moderate COPD, Time for Action!
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.
Read the 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
!!!! Remark (26/9/2013) Based on the last data analyses, in contrast to our expectations, we concluded that the two groups with a smoking history, with or without COPD change in a similar way over time. The length of the study will therefore be prolonged with 3 more years (6 years in total).
After 3 years the patients with a smoking history will be evaluated yearly, unless they were hospitalized for >5 days. In that case we will sooner contact these patients in order to pick up comorbidities in these patients.!!!
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- 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.
| Study group | Role | What they receive |
|---|---|---|
| patients with COPD | patients who were defined as COPD, based on post-bronchodilator spirometry (GOLD criteria). Patients will have at least 10 pack years | |
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of risk factors to develop comorbidities (vascular dysfunction, osteoporosis, muscle wasting and metabolic syndrome)
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 (fat free mass index < 15/16(female/male) and respiratory/peripheral muscle weakness; < 80%predicted), metabolic (syndrome): definition by AHA
Measured: baseline
Incidence and worsening of risk factors to develop comorbidities (vascular dysfunction, osteoporosis, muscle wasting and metabolic syndrome)
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 (fat free mass index < 15/16 (female/male) and respiratory/peripheral muscle weakness; < 80%predicted), metabolic (syndrome): definition by AHA
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startJun 2009
- Primary completionJun 2014 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thierry Troosters, KU Leuven
- Investigators
- Wim Janssens, Prof, Principal investigator, KU LeuvenThierry Troosters, Prof, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314807
- Sponsor's protocol ID
- The Rainbow study
- Status last verified
- Jan 2014
- First submitted
- 9 Mar 2011
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Rodrigues FM, Demeyer H, Loeckx M, Hornikx M, Van Remoortel H, Janssens W, Troosters T. Health status deterioration in subjects with mild to moderate airflow obstruction, a six years observational study. Respir Res. 2019 May 18;20(1):93. doi: 10.1186/s12931-019-1061-7.
PubMed 31103027Van Remoortel H, Hornikx M, Langer D, Burtin C, Everaerts S, Verhamme P, Boonen S, Gosselink R, Decramer M, Troosters T, Janssens W. Risk factors and comorbidities in the preclinical stages of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2014 Jan 1;189(1):30-8. doi: 10.1164/rccm.201307-1240OC.
PubMed 24219412
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Consequences and Comorbidities in Mild/Moderate COPD, Time for Action!
- ClinicalTrials.gov ID
- NCT01314807
- Acronym / sponsor ID
- The Rainbow study
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 15 Mar 2011 (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 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.
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
!!!! Remark (26/9/2013) Based on the last data analyses, in contrast to our expectations, we concluded that the two groups with a smoking history, with or without COPD change in a similar way over time. The length of the study will therefore be prolonged with 3 more years (6 years in total).
After 3 years the patients with a smoking history will be evaluated yearly, unless they were hospitalized for >5 days. In that case we will sooner contact these patients in order to pick up comorbidities in these patients.!!!
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with COPD | – | –patients who were defined as COPD, based on post-bronchodilator spirometry (GOLD criteria). Patients will have at least 10 pack years |
| 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) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Respiratory disorder other than COPD
- α1-antitrypsin deficiency
- Known history of significant inflammatory disease other than COPD
- COPD exacerbation within 4 weeks prior to study
- Lung surgery
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
Prevalence of risk factors to develop comorbidities (vascular dysfunction, osteoporosis, muscle wasting and metabolic syndrome)
Time frame: baseline
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 (fat free 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
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 (fat free mass index < 15/16 (female/male) and respiratory/peripheral muscle weakness; < 80%predicted), metabolic (syndrome): definition by AHA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
- Derived from this study: PubMed 31103027Rodrigues FM, Demeyer H, Loeckx M, Hornikx M, Van Remoortel H, Janssens W, Troosters T. Health status deterioration in subjects with mild to moderate airflow obstruction, a six years observational study. Respir Res. 2019 May 18;20(1):93. doi: 10.1186/s12931-019-1061-7.
- Derived from this study: PubMed 24219412Van Remoortel H, Hornikx M, Langer D, Burtin C, Everaerts S, Verhamme P, Boonen S, Gosselink R, Decramer M, Troosters T, Janssens W. Risk factors and comorbidities in the preclinical stages of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2014 Jan 1;189(1):30-8. doi: 10.1164/rccm.201307-1240OC.
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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.
Wim Janssens, Prof principal investigator
KU Leuven
Thierry Troosters, Prof principal investigator
KU Leuven
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 KU Leuven at 1 site in Belgium.
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 Jan 2014. 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 Belgium. 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?
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?
Prevalence of risk factors to develop comorbidities (vascular dysfunction, osteoporosis, muscle wasting and metabolic syndrome) (time frame: baseline). The study lists 2 primary outcomes in all. 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 NCT01314807, which also lists 2 linked publications.
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 Jan 2014.