Overview

This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease
Sponsor Katholieke Universiteit Leuven
Start date June 2009
End date June 2014
Trial size 200 participants
Trial identifier NCT01314807, The Rainbow study

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
patients who were defined as COPD, based on post-bronchodilator spirometry (GOLD criteria). Patients will have at least 10 pack years
patients with at least 10 pack years who have no COPD (based on post-bronchodilator spirometry)
patients with < 1 pack year who have no COPD (based on post-bronchodilator spirometry)

Primary Outcomes

Measure
Prevalence of risk factors to develop comorbidities (vascular dysfunction, osteoporosis, muscle wasting and metabolic syndrome)
time frame: baseline
Incidence and worsening of risk factors to develop comorbidities (vascular dysfunction, osteoporosis, muscle wasting and metabolic syndrome)
time frame: 3 years

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

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

Additional Information

Official title Systemic Consequences and Comorbidities in Mild/Moderate COPD, Time for Action!
Principal investigator Wim Janssens, Prof
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.!!!
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Katholieke Universiteit Leuven.