Clinical Assessment of Patients With Chronic Obstructive Pulmonary Disease (COPD) and/or Chronic Heart Failure (CHF)

COPD Clinical Trial

Official title:

Clinical, Functional and Biological Assessment of Patients With Chronic Obstructive Pulmonary Disease (COPD) and/or Chronic Heart Failure(CHF) in Stable Conditions and During Exacerbation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01114386
• Other study ID #: RFPS-2006-8-334056
• Status: Completed
• Phase: N/A
• First received: April 30, 2010
• Last updated: June 6, 2012
• Start date: October 2006
• Est. completion date: December 2011

Study information

• Verified date: June 2012
• Source: University of Modena and Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Cigarette smoking, the major risk factor for COPD, causes not only airway and lung inflammation, but also systemic effects. These systemic effects of smoking could substantially contribute to the development of chronic diseases, other than COPD, particularly chronic heart failure (CHF). The aim of this project is to assess the frequency and severity of CHF and COPD in outpatients with history of smoking referred to Hospital because of dyspnea and/or chronic cough.

Description:

We will recruit 100 patients older than 50 years with diagnosis of COPD and/or CHF. COPD is defined by presence of fixed airflow obstruction (post-bronchodilator FEV1/FVC less than 70%) according to Global Initiative for Obstructive Lung Disease (GOLD) guidelines. Each patient will be characterized by medical history and physical examination. Patients with a diagnosis of COPD must have: 1) had a history of chronic respiratory symptoms, i.e., cough and sputum and/or breathlessness and only occasional wheezing (SGRQ and MMRC Questionnaire); 2) they had to be smokers or ex-smokers with more than 10 pack-years, and 3) a documented absence of a history of variable airflow obstruction and/or diagnosis of asthma. Each patient will perform pulmonary function tests, including reversibility to inhaled bronchodilator (400 µg albuterol); arterial blood gases, and routine blood tests. In addition, each patient will undergo regular PA/LL chest x-ray. The diagnosis of CHF is established according to the criteria of European Society of Cardiology. At time of entry in the study, all patients will be in clinically stable condition (ie, no changes in medication dosage or frequency, and no exacerbations of disease or hospital admissions in the preceding 6 weeks). Clinical and biological follow-up of these patients will be prospectively followed for 2 years, from 2009 to 2011.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 95 Years

Eligibility

Inclusion Criteria:

• Caucasians

• Males and females

• Age > 50 years

• Smoking history > 10 pack years

• Diagnosis of COPD according to GOLD 2008 and/or diagnosis of CHF according to ESC 2008

Exclusion Criteria:

• History of bronchial asthma

• Fixed airflow limitation due to other chronic diseases such as cystic fibrosis, bronchiolitis obliterans organizing pneumonia (BOOP), bronchiectasis, TBC etc.

• Combined restrictive-obstructive functional impairment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• COPD
• Heart Failure
• Heart Failure, Congestive
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• Lung function testing, echocardiography, blood sampling
All patients will undergo to: physical examination 6' Minute Walk test pulmonary function testing (spirometry + volumes and reversibility testing) carbon monoxide diffusing capacity (DLCO) with single-breathe technique ECG echocardiography

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria di Modena	Modena

Sponsors (2)

Lead Sponsor	Collaborator
University of Modena and Reggio Emilia	Agenzia Italiana del Farmaco

Country where clinical trial is conducted

Italy,