Back to results

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

Primary Purpose

Anemia, COPD

Status

Completed

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

maximal cardiopulmonary exercise testing

peripheral blood samples

About this trial

This is an interventional screening trial for Anemia focused on measuring COPD, anemia, exercise, cytokines, erythropoietin

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Pulmonology, Aristotle University of Thessaloniki
Respiratory Failure Unit, General Hospital "G. Papanikolaou"

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

COPD patients with ACD

COPD patients without ACD

Arm Description

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.

Thirty matched patients with COPD without ACD from the initial cohort will constitute the second arm (the "controls")

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Serum levels of inflammatory markers

Erythropoietin

MRC dyspnea scale

The rest cardiopulmonary exercise testing parameters

Full Information

NCT ID

NCT01033175

First Posted

December 15, 2009

Last Updated

July 6, 2010

Sponsor

Aristotle University Of Thessaloniki

1. Study Identification

Unique Protocol Identification Number

NCT01033175

Brief Title

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

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Aristotle University Of Thessaloniki

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia, COPD

Keywords

COPD, anemia, exercise, cytokines, erythropoietin

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

COPD patients with ACD

Arm Type

Other

Arm Description

Arm Title

COPD patients without ACD

Arm Type

Other

Arm Description

Thirty matched patients with COPD without ACD from the initial cohort will constitute the second arm (the "controls")

Intervention Type

Procedure

Intervention Name(s)

maximal cardiopulmonary exercise testing

Intervention Description

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).

Intervention Type

Procedure

Intervention Name(s)

peripheral blood samples

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time Frame