Clinical trial NCT01033175: The Impact of Anemia of Chronic Disease on Chronic Obstructive Pulmonary Disease Patients
Official title: The Clinical Impact of Anemia of Chronic Disease on Chronic Obstructive Pulmonary Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
COPD
Keywords: COPD
anemia
exercise
cytokines
erythropoietin
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2009-12-16
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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).


Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: Within 15 days from enrollment
Secondary outcomes:
measure: Serum levels of inflammatory markers
timeFrame: Within 15 days from enrollment
measure: Erythropoietin
timeFrame: Within 15 days from enrollment
measure: MRC dyspnea scale
timeFrame: Within 15 days from enrollment
measure: The rest cardiopulmonary exercise testing parameters
timeFrame: Within 15 days from enrollment
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Department of Pulmonology, Aristotle University of Thessaloniki
city: Thessaloniki
country: Greece
facility: Respiratory Failure Unit, General Hospital "G. Papanikolaou"
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Paraskevi Argyropoulou, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.