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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • University Hospital Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: KU Leuven

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ANTICIPATED): June 1, 2014
• Study Completion (ANTICIPATED): January 1, 2018

Study Registration Dates

• First Submitted: March 9, 2011
• First Submitted That Met QC Criteria: March 14, 2011
• First Posted (ESTIMATE): March 15, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 29, 2014
• Last Update Submitted That Met QC Criteria: January 28, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: The Rainbow study