Monitoring Chronic Obstructive Pulmonary Disease Patients at Home by a Forced Oscillation Technique Device

Summary

Chronic obstructive pulmonary disease (COPD) is a pathological condition whose progression is characterized by stable periods broken up by intermittent acute exacerbations of the symptoms, during which a severe inflammatory process occurs often requiring hospitalization. During exacerbations the risk of death is very high making the social and economical impact of such events important.

The need of rationalize the utilization of health care resources together with the optimization of patient's care has prompted the development of models of assistance based on home monitoring. At the present time most of the suggested models were based on the utilization of diaries for symptoms perceived by the patients. Even if positive results are reported in terms of reduction of in hospitalization many COPD patients tend to underestimate the severity of their condition and their compliance in recording their symptoms rapidly decreases with time.

Attempts of using more objective measurements such as home spirometers have been done but poor results were reported mainly due to the difficulties in performing a spirometric test without medical supervision.

A more suitable approach to get objective information on the function of the respiratory system is the Forced Oscillation Technique (FOT). Such methodology is based on the analysis of the response of the system to small pressure stimuli over-imposed to the normal breathing of the patients. The measurements require minimal cooperation and can be performed without medical supervision.

The purpose of this study is to measure daily variability of FOT data measured at home of a group of COPD patients in order to identify possible correlations between symptoms change, breathing pattern, lung mechanical impedance and occurrence of exacerbation.

Conditions

• COPD

Sponsors & Collaborators

• Restech Srl

  collaborator INDUSTRY

• Politecnico di Milano

  collaborator OTHER

• Fondazione Salvatore Maugeri

  collaborator OTHER

• Azienda Ospedaliera S. Luigi, Orbassano (TO)

  collaborator UNKNOWN

• Baylor College of Medicine

  collaborator OTHER

• Ospedale di Circolo e Fondazione Macchi, Varese

  collaborator UNKNOWN

• Woolcock Institute of Medical Research

  collaborator OTHER

• Raffaele Dellaca

  lead OTHER

Principal Investigators

• Raffaele L Dellaca', PhD · Politecnico di Milano, Italy

• Michele Vitacca, MD · Pneumology Division Fondazione Salvatore Maugeri, IRCCS, Lumezzane, Italy

• Alessandro Gobbi, PhD · Politecnico di Milano, Italy

• Pasquale P Pompilio, PhD · Politecnico di Milano, Italy

• Emanuela Zannin, PhD · Politecnico di Milano, Italy

• Carlo Gulotta, MD · Pneumologia-Fisiopatologia Respiratoria, Azienda Ospedaliera S. Luigi Gonzaga Orbassano, Torino, Italy

• Amir Sharafkhaneh, MD, PhD · Sleep Disorders & Research Center Michael E. DeBakey VA Medical Center

• Piero Ceriana, MD · Unità Operativa di Riabilitazione Pneumologica, Fondazione Salvatore Maugeri, IRCCS, Pavia, Italy

• Fausto Colombo, MD · Direttore U.O. Pneumologia - A.O. Ospedale di Circo lo e Fondazione Macchi, Varese

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-11-30

Primary Completion

2017-12-31

Completion

2018-07-31

Countries

• Australia
• Italy

Study Locations