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

This study is currently recruiting participants.
Verified December 2013 by Politecnico di Milano
Sponsor:
Collaborators:
Restech srl - spinoff del Politecnico di Milano
Politecnico di Milano
Fondazione Salvatore Maugeri, Pavia
Azienda Ospedaliera S. Luigi, Orbassano (TO)
Baylor College of Medicine
Ospedale di Circolo e Fondazione Macchi, Varese
Information provided by (Responsible Party):
Raffaele Dellaca, Politecnico di Milano
ClinicalTrials.gov Identifier:
NCT01552031
First received: March 6, 2012
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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.


Condition
COPD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monitoring COPD Patients at Home by a Forced Oscillation Technique Device

Resource links provided by NLM:


Further study details as provided by Politecnico di Milano:

Primary Outcome Measures:
  • Day-by-day changes of lung mechanical impedance [ Time Frame: Every day for 8 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Every day for 8 months ] [ Designated as safety issue: No ]
    Changes of perceived symptoms as reported by the patients no the RESMONPRO device

  • Day-by-day changes of patient activity [ Time Frame: Every day for 8 months ] [ Designated as safety issue: No ]
    level of activity of the patient as recorded by the Actiwatch.

  • Number of exacerbation [ Time Frame: 8 months ] [ Designated as safety issue: No ]

    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


  • Day-by-day changes of breathing pattern [ Time Frame: Every day for 8 months ] [ Designated as safety issue: No ]
    Changes in breathing pattern measured while performing FOT by RESMONPRO device


Estimated Enrollment: 80
Study Start Date: November 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observational group

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

80 COPD patients, with the characteristics of frequent exacerbators (> 2 exacerbations in the past year), will be enrolled in the study.

Criteria

Inclusion Criteria:

  • 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

better if:

  • depressive phenotype
  • worsening of dyspnea during walk (measured by MRC-Medical Research Council score)
  • malnutrition or obesity (BMI < 19 or > 25)
  • patient lives alone

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552031

Contacts
Contact: Raffaele L Dellaca', PhD +393804799108 raffaele.dellaca@polimi.it

Locations
United States, Texas
Baylor College of Medicine Suspended
Houston, Texas, Texas, United States, 77030
Italy
Divisione di Pneumologia, Fondazione S. Maugeri, IRCCS Recruiting
Lumezzane, BS, Italy
Contact: Michele Vitacca, MD       michele.vitacca@fsm.it   
Principal Investigator: Michele Vitacca, MD         
Pneumologia-Fisiopatologia Respiratoria, Azienda Ospedaliera S. Luigi Gonzaga Recruiting
Orbassano, Torino, Italy
Contact: Carlo Gulotta, MD       c.gulotta@sanluigi.piemonte.it   
Principal Investigator: Carlo Gulotta, MD         
Unità Operativa di Riabilitazione Pneumologica, Fondazione S. Maugeri, IRCCS Recruiting
Pavia, Italy, 27100
Contact: Piero Ceriana, MD       piero.ceriana@fsm.it   
Principal Investigator: Piero Ceriana, MD         
U.O. Pneumologia - A.O. Ospedale di Circolo e Fondazione Macchi Recruiting
Varese, Italy, 21100
Contact: Fausto Colombo, MD       fausto.colombo@ospedale.varese.it   
Principal Investigator: Fausto Colombo         
Sponsors and Collaborators
Raffaele Dellaca
Restech srl - spinoff del Politecnico di Milano
Politecnico di Milano
Fondazione Salvatore Maugeri, Pavia
Azienda Ospedaliera S. Luigi, Orbassano (TO)
Baylor College of Medicine
Ospedale di Circolo e Fondazione Macchi, Varese
Investigators
Principal Investigator: Raffaele L Dellaca', PhD Politecnico di Milano, Italy
Principal Investigator: Michele Vitacca, MD Pneumology Division Fondazione Salvatore Maugeri, IRCCS, Lumezzane, Italy
Principal Investigator: Alessandro Gobbi, PhD Politecnico di Milano, Italy
Principal Investigator: Pasquale P Pompilio, PhD Politecnico di Milano, Italy
Principal Investigator: Emanuela Zannin, PhD Politecnico di Milano, Italy
Principal Investigator: Carlo Gulotta, MD Pneumologia-Fisiopatologia Respiratoria, Azienda Ospedaliera S. Luigi Gonzaga Orbassano, Torino, Italy
Principal Investigator: Amir Sharafkhaneh, MD, PhD Sleep Disorders & Research Center Michael E. DeBakey VA Medical Center
Principal Investigator: Piero Ceriana, MD Unità Operativa di Riabilitazione Pneumologica, Fondazione Salvatore Maugeri, IRCCS, Pavia, Italy
Principal Investigator: Fausto Colombo, MD Direttore U.O. Pneumologia - A.O. Ospedale di Circo lo e Fondazione Macchi, Varese
  More Information

Publications:

Responsible Party: Raffaele Dellaca, Professor, Politecnico di Milano
ClinicalTrials.gov Identifier: NCT01552031     History of Changes
Other Study ID Numbers: COPD-FOT-MON1
Study First Received: March 6, 2012
Last Updated: December 3, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Politecnico di Milano:
COPD exacerbations
FOT variability

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014