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CompletedNCT01033175Updated Jul 7, 2010

The Impact of Anemia of Chronic Disease on Chronic Obstructive Pulmonary Disease Patients

An interventional study of maximal cardiopulmonary exercise testing and peripheral blood samples in Anemia and COPD, sponsored by Aristotle University Of Thessaloniki. Completed at 2 sites in Greece. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2010-07-07.

Sponsored by Aristotle University Of Thessaloniki · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
40 Years to 85 Years
Sex
All
01

Study summary

Hypothesis:

The first part of the study is a survey on the prevalence of anemia of chronic disease (ACD) among COPD patients. The 2nd and 3rd part will test 2 null hypotheses (Ho): 1.serum inflammatory markers and plasma erythropoietin do not differ between COPD patients with and without ACD and 2. exercise capacity does not differ between COPD patients with and without ACD.

Rationale-Aim:

ACD is an immune driven disorder, developing in subjects suffering from chronic inflammatory diseases. COPD is a disorder very likely to be associated to ACD due to its systemic inflammatory dimension. Currently, data on the prevalence of ACD and on the level of inflammatory markers which are implicated in the pathogenesis of ACD in COPD subjects are limited and controversial. Furthermore, there is no data on the effect of ACD on exercise capacity of COPD subjects.

Based to the aforementioned, this study has three goals:

  1. to determine the prevalence and the epidemiologic characteristics of ACD in a population of clinical stable COPD patients
  2. to investigate whether the levels of serum inflammatory markers and of plasma erythropoietin differ between COPD patients with ACD and without ACD
  3. to determine potential differences regarding the aerobic exercise capacity between these two groups, using the cardiopulmonary exercise testing (CPET).
02

Conditions studied

  • Anemia
  • COPD

Keywords

  • COPD
  • anemia
  • exercise
  • cytokines
  • erythropoietin
03

In context

Lung Diseases, Obstructive

2,591 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's planned enrollment of 60 is close to the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

Aristotle University Of Thessaloniki is the lead sponsor of 274 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 1st part of the study:

    • COPD clinically stable (patients with post-bronchodilation FEV1/FVC \<0.7 and no acute exacerbations, hospital admissions or treatment changes in the last 3 months).
    • 2nd and 3rd part:
    • As above.

Exclusion criteria

Exclusion Criteria:

  • 1st part of the study:

    • history of asthma,
    • history of respiratory infection in the last 3 months

  • 2nd and 3rd part: As above and additionally:

    • history of malignancy or haematologic disorder
    • acute or chronic inflammatory disease
    • systematic or autoimmune disorder
    • thyroid disease
    • liver cirrhosis
    • heart failure (ejection fraction \<55%)
    • history of gastrointestinal or other hemorrhage
    • renal failure (GFR\<60 ml/min/1.73m2)
    • blood transfusion in the last 4 months
    • administration of cortisone in the last month
    • pregnancy
    • mental impairment
    • medical conditions which are contraindications to exercise testing, such as:
  • acute myocardial infarction (in the last 6 months)
  • unstable angina
  • left main coronary stenosis or its equivalent
  • syncope
  • symptomatic severe aortic stenosis or other moderate stenotic valvular disease
  • uncontrolled arrhythmias causing symptoms
  • acute pulmonary embolus or pulmonary infarction
  • thrombosis of lower extremities
  • suspected dissecting aneurysm
  • pulmonary oedema
  • room air desaturation at rest \<85%
  • severe untreated arterial hypertension at rest (>200 mmHg systolic, >120 mmHg diastolic)
  • high degree atrioventricular block
  • hypertrophic cardiomyopathy and
  • orthopedic impairment that compromises exercise performance
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Other
    COPD patients with ACD

    In the 1st part of this clinical study the prevalence ACD in COPD subjects will be estimated in a consecutive population of COPD subjects who will visit the hospital's pulmonary clinics as outpatients. During the first visit, subjects will give a detailed medical history and will undergo clinical examination and pulmonary function testing 15 minutes post-bronchodilation. Eligible patients will then undergo peripheral venous blood analysis. The first 30 COPD subjects from the population described above, fulfilling the criteria of ACD will constitute the first arm (group of "cases").ACD is defined by low Hb levels (men: \<13 mg/dl, women: \<12 mg/dl), no other cause of anemia present, normal or increased serum ferritin and decreased total iron binding capacity.

    Procedure: maximal cardiopulmonary exercise testing · Procedure: peripheral blood samples

  • Other
    COPD patients without ACD

    Thirty matched patients with COPD without ACD from the initial cohort will constitute the second arm (the "controls")

    Procedure: maximal cardiopulmonary exercise testing · Procedure: peripheral blood samples

Interventions

  • Proceduremaximal cardiopulmonary exercise testing

    Cardiopulmonary exercise testing (CPET) will be performed on a cyclic ergometer with continuous monitoring of a 12-lead electrocardiogram, heart rate and blood pressure. While breathing with a mask, the patients will perform a ramp protocol which includes 2-minutes free pedaling and progressive increase of power by 10, 15 or 20 watts/minute; power size will be selected after considering the patient' s daily activity and parameters of pulmonary function. CPET will be performed until exhaustion, unless the subjects reveal symptoms or signs indicating the exercise should stop (e.g. severe breathlessness).

  • Procedureperipheral blood samples

    Peripheral venous blood samples will be collected again in the morning after a fasting period of ≥12 hours. After immediate centrifugation, aliquots will be stored at -75˚C until analysis. Inflammatory markers and erythropoietin will be analyzed by flow cytometry and by enzyme-linked immunosorbent assay, using commercially available kits.

06

What researchers measure

Primary outcomes

  1. The primary outcome measure is peak oxygen uptake (VO2 peak, ml/kg/min) during maximal cardiopulmonary exercise testing and whether it differs between patients with ACD and COPD and patients with COPD without ACD.

    Time frame: Within 15 days from enrollment

Secondary outcomes

  1. Serum levels of inflammatory markers

    Time frame: Within 15 days from enrollment

  2. Erythropoietin

    Time frame: Within 15 days from enrollment

  3. MRC dyspnea scale

    Time frame: Within 15 days from enrollment

  4. The rest cardiopulmonary exercise testing parameters

    Time frame: Within 15 days from enrollment

07

Study locations

2 sites
  • Department of Pulmonology, Aristotle University of Thessaloniki
    Thessaloniki, 57010, Greece
  • Respiratory Failure Unit, General Hospital "G. Papanikolaou"
    Thessaloniki, 57010, Greece
08

References and documents

Publications

  • Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. doi: 10.1056/NEJMra041809. No abstract available. PubMed 15758012 ↗
  • Standards for the diagnosis and care of patients with chronic obstructive pulmonary disease. American Thoracic Society. Am J Respir Crit Care Med. 1995 Nov;152(5 Pt 2):S77-121. No abstract available. PubMed 7582322 ↗
  • American Thoracic Society; American College of Chest Physicians. ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 Jan 15;167(2):211-77. doi: 10.1164/rccm.167.2.211. No abstract available. Erratum In: Am J Respir Crit Care Med. 2003 May 15;1451-2. PubMed 12524257 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01033175
Lead sponsor
Aristotle University Of Thessaloniki
First posted
Dec 16, 2009
Start date
Dec 2009
Primary completion
May 2010
Completion
Jun 2010
Last update
Jul 7, 2010

Study contacts

Paraskevi Argyropoulou, MD, Prof
principal investigator · Aristotle University Of Thessaloniki

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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