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

NCT01314807 | Unknown

• 1 other identifier: The Rainbow study
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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). Special attention will be paid to skeletal muscle dysfunction and physical inactivity as these factors are, together with smoking, potentially modifiable.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (2)

• 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

  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

  3 years

Study Arms (3)

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)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

University Hospital Leuven

Leuven, 3000, Belgium

Location

Related Publications (2)

• 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.

  PMID: 31103027 DERIVED

• Van 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.

  PMID: 24219412 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wim Janssens, Prof

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Thierry Troosters, Prof

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 9, 2011
• First Posted: March 15, 2011
• Study Start: June 1, 2009
• Primary Completion: June 1, 2014
• Study Completion: January 1, 2018
• Last Updated: January 29, 2014

Record last verified: 2014-01

Locations

BE (1)