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

This study has been completed.
Sponsor:
Information provided by:
Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT01033175
First received: December 15, 2009
Last updated: July 6, 2010
Last verified: December 2009

December 15, 2009
July 6, 2010
December 2009
May 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01033175 on ClinicalTrials.gov Archive Site
  • Serum levels of inflammatory markers [ Time Frame: Within 15 days from enrollment ] [ Designated as safety issue: No ]
  • Erythropoietin [ Time Frame: Within 15 days from enrollment ] [ Designated as safety issue: No ]
  • MRC dyspnea scale [ Time Frame: Within 15 days from enrollment ] [ Designated as safety issue: No ]
  • The rest cardiopulmonary exercise testing parameters [ Time Frame: Within 15 days from enrollment ] [ Designated as safety issue: No ]
Serum levels of:a)TNF-a, b)IL-6, c)IL-1, d)IL-10, e)iNF-γ, f)CRP, g)Erythropoietin and the following cardiopulmonary exercise testing parameters: a) anaerobic threshold (AT), b) peak minute ventilation, c) peak work rate, d) peak oxygen pulse [ Time Frame: Within 15 days from enrollment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Impact of Anemia of Chronic Disease on Chronic Obstructive Pulmonary Disease Patients
The Clinical 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).
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
  • Anemia
  • COPD
  • Procedure: maximal 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).
  • Procedure: peripheral 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.
  • 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.
    Interventions:
    • Procedure: maximal cardiopulmonary exercise testing
    • Procedure: peripheral blood samples
  • COPD patients without ACD
    Thirty matched patients with COPD without ACD from the initial cohort will constitute the second arm (the "controls")
    Interventions:
    • Procedure: maximal cardiopulmonary exercise testing
    • Procedure: peripheral blood samples

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
40 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01033175
8/22.1.08
No
Paraskevi Argyropoulou, Professor of Pulmonology, Aristotle University of Thessaloniki
Aristotle University Of Thessaloniki
Not Provided
Principal Investigator: Paraskevi Argyropoulou, MD, Prof Aristotle University Of Thessaloniki
Aristotle University Of Thessaloniki
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP