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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01033175
• Other study ID #: 8/22.1.08
• Status: Completed
• Phase: N/A
• First received: December 15, 2009
• Last updated: July 6, 2010
• Start date: December 2009
• Est. completion date: June 2010

Study information

• Verified date: December 2009
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Anemia
• Chronic Disease
• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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).
• 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.

Locations

Country	Name	City	State
Greece	Department of Pulmonology, Aristotle University of Thessaloniki	Thessaloniki
Greece	Respiratory Failure Unit, General Hospital "G. Papanikolaou"	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

References & Publications (3)

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. Review. Erratum in: Am J Respir Crit Care Med. 2003 May 15;1451-2. — View 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. Review. — View Citation

Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Serum levels of inflammatory markers		Within 15 days from enrollment	No
Secondary	Erythropoietin		Within 15 days from enrollment	No
Secondary	MRC dyspnea scale		Within 15 days from enrollment	No
Secondary	The rest cardiopulmonary exercise testing parameters		Within 15 days from enrollment	No