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

Not Applicable

Completed

• Conditions: Anemia; COPD
• Interventions: Procedure: maximal cardiopulmonary exercise testing; Procedure: peripheral blood samples

• Registration Number: NCT01033175
• Lead Sponsor: Aristotle University Of Thessaloniki

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. 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-12
• Study Start: 2009-12
• Study First Submitted: 2009-12-15
• Study First Submitted QC: 2009-12-15
• Study First Posted: 2009-12-16
• Primary Completion: 2010-05
• Study Completion: 2010-06
• Last Update Submitted: 2010-07-06
• Last Update Posted: 2010-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COPD patients with ACD	maximal cardiopulmonary exercise testing	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.
COPD patients with ACD	peripheral blood samples	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.
COPD patients without ACD	maximal cardiopulmonary exercise testing	Thirty matched patients with COPD without ACD from the initial cohort will constitute the second arm (the "controls")
COPD patients without ACD	peripheral blood samples	Thirty matched patients with COPD without ACD from the initial cohort will constitute the second arm (the "controls")

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Erythropoietin	Within 15 days from enrollment
MRC dyspnea scale	Within 15 days from enrollment
Serum levels of inflammatory markers	Within 15 days from enrollment
The rest cardiopulmonary exercise testing parameters	Within 15 days from enrollment

Trial Locations

Locations (2)

Department of Pulmonology, Aristotle University of Thessaloniki; 🇬🇷 Thessaloniki, Greece

Respiratory Failure Unit, General Hospital "G. Papanikolaou"; 🇬🇷 Thessaloniki, Greece