Systemic Consequences and Comorbidities in Mild/Moderate Chronic Obstructive Pulmonary Disease (COPD), Time for Action!

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Thierry Troosters, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01314807
First received: March 9, 2011
Last updated: January 28, 2014
Last verified: January 2014
  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!

Resource links provided by NLM:


Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • 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 (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 ] [ 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 (fat free mass index < 15/16 (female/male) and respiratory/peripheral muscle weakness; < 80%predicted), metabolic (syndrome): definition by AHA


Biospecimen Retention:   Samples Without DNA

whole blood, cholesterol, LDL, HDL, creatinine, fibrinogen, glucose, insuline, NTproBNP, CRP, Hba1C


Estimated Enrollment: 200
Study Start Date: June 2009
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
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
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

!!!! 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.!!!

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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

Criteria

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-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
  • Therapy with oral corticosteroids in the last 6 weeks
  • Significant cardiovascular comorbidity
  • Significant orthopedic/musculoskeletal problems
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01314807

Locations
Belgium
University Hospital Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
Investigators
Principal Investigator: Wim Janssens, Prof Katholieke Universiteit Leuven
Principal Investigator: Thierry Troosters, Prof Katholieke Universiteit Leuven
  More Information

No publications provided by Katholieke Universiteit Leuven

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thierry Troosters, Prof. Dr., 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: January 28, 2014
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 July 24, 2014