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NCT Number: NCT01033175

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

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).

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Key information

Conditions

Anemia Behavior COPD Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pulmonology, Aristotle University of Thessaloniki, Thessaloniki, Greece

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

maximal cardiopulmonary exercise testing

Procedure

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).

peripheral blood samples

Procedure

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.

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

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 16, 2009
Registry last updated
Jul 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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