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Clinical trialNCT01552031UnknownObservational

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

SponsorRaffaele DellacaEnrollment80COPD
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Alessandro Gobbi, PhD

    Politecnico di Milano, Italy

    Principal Investigator
  • Amir Sharafkhaneh, MD, PhD

    Sleep Disorders & Research Center Michael E. DeBakey VA Medical Center

    Principal Investigator
  • Carlo Gulotta, MD

    Pneumologia-Fisiopatologia Respiratoria, Azienda Ospedaliera S. Luigi Gonzaga Orbassano, Torino, Italy

    Principal Investigator
  • Emanuela Zannin, PhD

    Politecnico di Milano, Italy

    Principal Investigator
  • Fausto Colombo, MD

    Direttore U.O. Pneumologia - A.O. Ospedale di Circo lo e Fondazione Macchi, Varese

    Principal Investigator
  • Michele Vitacca, MD

    Pneumology Division Fondazione Salvatore Maugeri, IRCCS, Lumezzane, Italy

    Principal Investigator
  • Pasquale P Pompilio, PhD

    Politecnico di Milano, Italy

    Principal Investigator
  • Piero Ceriana, MD

    Unità Operativa di Riabilitazione Pneumologica, Fondazione Salvatore Maugeri, IRCCS, Pavia, Italy

    Principal Investigator
  • Raffaele L Dellaca', PhD

    Politecnico di Milano, Italy

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia
  • Woolcock Institute of Medical Research

    Glebe, New South Wales, Australia

    Cindy Thamrin, PhD
    Recruiting
Italy
  • Divisione Di Pneumologia, Fondazione S. Maugeri, Irccs

    Lumezzane, BS, Italy

    Completed
  • Pneumologia-Fisiopatologia Respiratoria, Azienda Ospedaliera S. Luigi Gonzaga

    Orbassano, Torino, Italy

    Completed
  • Unità Operativa Di Riabilitazione Pneumologica, Fondazione S. Maugeri, Irccs

    Pavia, Italy

    Completed
  • U.O. Pneumologia - A.O. Ospedale Di Circolo E Fondazione Macchi

    Varese, Italy

    Completed

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Nov 2011
Primary completion
31 Dec 2017
Completion
31 Jul 2018
Last update posted
6 Mar 2017
Registered enrollment
80
Registry id
NCT01552031

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.