跳至主要内容
临床试验/NCT01552031
NCT01552031Unknown不适用

Monitoring COPD Patients at Home by a Forced Oscillation Technique Device

Raffaele Dellaca5 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
5
主要终点
Day-by-day changes of breathing pattern

研究概览

简要总结

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.

详细描述

The continuous progresses of medical science and technology and the improvement of life conditions have increased the life expectancy in industrialized countries: the result is the progressive population aging [UN, 2002]. One of the consequences of this trend is the increasing number of people suffering from chronic diseases.

Among these pathologies chronic obstructive pulmonary disease (COPD) is the more important for number of patients and deaths affecting 80 million people in the world [WHO, 2006]. The time course of the disease is characterized by stable periods broken up by intermittent acute exacerbations of the symptoms, during which a severe inflammatory process occurs, leading to increased airways obstruction. During exacerbations the risk of death is very high [Connors et al, 1996;Soler-Cataluna et al, 2005]. Moreover the frequency and severity of exacerbations correlate with the worsening of the health condition of the patient [Anzueto et al, 2009; Donaldson et al, 2002].

The burden of care of patients with COPD on the national health care systems and society is high. The utilization of health care resources by patients with COPD is primarily due to acute exacerbations requiring care in the emergency rooms and hospital [Dal Negro, 2008] .

In the last few years the need to rationalize the health care costs has prompted to the development of new technologies for the home monitoring of these patients mainly aimed at the early detection of the onset of exacerbations. This could help the development of new therapeutic and organizational models aimed at reducing the impact of such events on the quality of life of the patient and on the national health care systems.

Published data offer several different follow-up models of home monitoring of COPD. Written and electronic diaries, questionnaires, telephonic assistance by respiratory nurses or specialized clinical personnel and use of web-based call centers have all been suggested for the follow up of patients after discharge from hospitals. Even if positive results are reported in terms of reduction of in hospitalization [Vitacca et al, 2009] many COPD patients tend to underestimate the severity of their condition [Cote et al, 1998] and patient's compliance in recording their symptoms rapidly decreases with time [Cote et al, 1998]. Moreover, other authors address the difficulty to evaluate correctly the impact of such models on patient's quality of life and on the reduction of hospitalization and mortality rate [Ram et al, 2004; Bolton et al, 2010].

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COPD at stage 3 and 4 of GOLD classification(spirometric values after bronchodilator: FEV1/VC < 95th percentile of predicted and FEV1 < 50% of predicted)
  • patients who reported more than two exacerbations in the past year OR
  • patients who required more than two hospital admission in the last year OR
  • patients with ER admission in the last year due to acute respiratory failure
  • depressive phenotype
  • worsening of dyspnea during walk (measured by MRC-Medical Research Council score)
  • malnutrition or obesity (BMI < 19 or > 25)
  • patient lives alone

排除标准

  • Other respiratory diseases
  • Alpha-1antitrypsin deficiency
  • Significant inflammatory diseases other than COPD
  • Organ or systemic diseases that may impair the ventilatory function (any restrictive pulmonary disease, cystic fibrosis and so on)
  • Prior lung surgery
  • Concomitant enrollment in other trials
  • Any major non-COPD disease or condition, such as uncontrolled malignancy, end-stage heart disease, liver or renal insufficiency (that requires current evaluation for liver or renal transplantation or dialysis), amyotrophic lateral sclerosis, or severe stroke, or other as deemed appropriate by investigator as determined by review of medical history and / or patient reported medical history

结局指标

主要结局

Day-by-day changes of breathing pattern

时间窗: Every day for 8 months

Changes in breathing pattern measured while performing FOT by RESMONPRO device

Day-by-day changes of lung mechanical impedance

时间窗: Every day for 8 months

Changes in within-breath total respiratory input impedance (Zrs), resistance (Rrs) and Reactance (Xrs) measured day-by-day by the RESMONPRO device

Day-by-day changes of patient's symptom

时间窗: Every day for 8 months

Changes of perceived symptoms as reported by the patients no the RESMONPRO device

Day-by-day changes of patient activity

时间窗: Every day for 8 months

level of activity of the patient as recorded by the Actiwatch.

Number of exacerbation

时间窗: 8 months

On the basis of the presence of the following events an exacerbation will be detected and classified as: Mild exacerbation: changes in current treatment or prescription of a short acting bronchodilator Intermediate exacerbation: prescription of a steroids per os Severe exacerbation: prescription of systemic antibiotic Very severe exacerbation: hospital admission

次要结局

未报告次要终点

研究者

发起方
Raffaele Dellaca
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Raffaele Dellaca

Professor

Politecnico di Milano

研究点 (5)

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