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

NCT01033175 | Completed

• 1 other identifier: 8/22.1.08
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Conditions

Anemia; COPD

Keywords

COPD; anemia; exercise; cytokines; erythropoietin

Outcome Measures

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.

  Within 15 days from enrollment

Secondary Outcomes (4)

• Serum levels of inflammatory markers

  Within 15 days from enrollment

• Erythropoietin

  Within 15 days from enrollment

• MRC dyspnea scale

  Within 15 days from enrollment

• The rest cardiopulmonary exercise testing parameters

  Within 15 days from enrollment

Study Arms (2)

COPD patients with ACD

OTHER

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

COPD patients without ACD

OTHER

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

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).

COPD patients with ACD; COPD patients without ACD

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.

COPD patients with ACD; COPD patients without ACD

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• st 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).
• nd and 3rd part:
• As above.

You may not qualify if:

• st part of the study:
• history of asthma,
• history of respiratory infection in the last 3 months
• nd 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (2)

Department of Pulmonology, Aristotle University of Thessaloniki

Thessaloniki, 57010, Greece

Location

Respiratory Failure Unit, General Hospital "G. Papanikolaou"

Thessaloniki, 57010, Greece

Location

Related Publications (3)

• 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.

  PMID: 15758012 BACKGROUND

• 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.

  PMID: 7582322 BACKGROUND

• 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.

  PMID: 12524257 BACKGROUND

MeSH Terms

Conditions

Anemia; Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Paraskevi Argyropoulou, MD, Prof

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 15, 2009
• First Posted: December 16, 2009
• Study Start: December 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 7, 2010

Record last verified: 2009-12

Locations

GR (2)