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

NCT01552031 | Unknown

• 1 other identifier: COPD-FOT-MON1
• Study Type: observational
• Target: 80
• Locations: 2 countries
• Sites: 5

Brief 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

Keywords

COPD exacerbations; FOT variability

Outcome Measures

Primary Outcomes (5)

• Day-by-day changes of lung mechanical impedance

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

  Every day for 8 months

• Day-by-day changes of patient's symptom

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

  Every day for 8 months

• Day-by-day changes of patient activity

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

  Every day for 8 months

• Number of exacerbation

  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

  8 months

• Day-by-day changes of breathing pattern

  Changes in breathing pattern measured while performing FOT by RESMONPRO device

  Every day for 8 months

Study Arms (1)

Observational group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Raffaele Dellaca: lead
• Restech Srl: collaborator
• Politecnico di Milano: collaborator
• Fondazione Salvatore Maugeri: collaborator
• Azienda Ospedaliera S. Luigi, Orbassano (TO): collaborator
• Baylor College of Medicine: collaborator
• Ospedale di Circolo e Fondazione Macchi, Varese: collaborator
• Woolcock Institute of Medical Research: collaborator

Study Sites (5)

Woolcock Institute of Medical Research

Glebe, New South Wales, 2037, Australia

RECRUITING

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, 27100, Italy

COMPLETED

U.O. Pneumologia - A.O. Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

COMPLETED

Related Publications (17)

• United Nations Population Division, World Population Ageing: 1950-2050 2002.

  BACKGROUND

• Connors AF Jr, Dawson NV, Thomas C, Harrell FE Jr, Desbiens N, Fulkerson WJ, Kussin P, Bellamy P, Goldman L, Knaus WA. Outcomes following acute exacerbation of severe chronic obstructive lung disease. The SUPPORT investigators (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments). Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):959-67. doi: 10.1164/ajrccm.154.4.8887592.

  PMID: 8887592 BACKGROUND

• Soler-Cataluna JJ, Martinez-Garcia MA, Roman Sanchez P, Salcedo E, Navarro M, Ochando R. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax. 2005 Nov;60(11):925-31. doi: 10.1136/thx.2005.040527. Epub 2005 Jul 29.

  PMID: 16055622 BACKGROUND

• Anzueto A, Leimer I, Kesten S. Impact of frequency of COPD exacerbations on pulmonary function, health status and clinical outcomes. Int J Chron Obstruct Pulmon Dis. 2009;4:245-51. doi: 10.2147/copd.s4862. Epub 2009 Jul 20.

  PMID: 19657398 BACKGROUND

• Donaldson GC, Seemungal TA, Bhowmik A, Wedzicha JA. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax. 2002 Oct;57(10):847-52. doi: 10.1136/thorax.57.10.847.

  PMID: 12324669 BACKGROUND

• Dal Negro R. Optimizing economic outcomes in the management of COPD. Int J Chron Obstruct Pulmon Dis. 2008;3(1):1-10. doi: 10.2147/copd.s671.

  PMID: 18488425 BACKGROUND

• Vitacca M, Bianchi L, Guerra A, Fracchia C, Spanevello A, Balbi B, Scalvini S. Tele-assistance in chronic respiratory failure patients: a randomised clinical trial. Eur Respir J. 2009 Feb;33(2):411-8. doi: 10.1183/09031936.00005608. Epub 2008 Sep 17.

  PMID: 18799512 BACKGROUND

• Rennard S, Decramer M, Calverley PM, Pride NB, Soriano JB, Vermeire PA, Vestbo J. Impact of COPD in North America and Europe in 2000: subjects' perspective of Confronting COPD International Survey. Eur Respir J. 2002 Oct;20(4):799-805. doi: 10.1183/09031936.02.03242002.

  PMID: 12412667 BACKGROUND

• Cote J, Cartier A, Malo JL, Rouleau M, Boulet LP. Compliance with peak expiratory flow monitoring in home management of asthma. Chest. 1998 Apr;113(4):968-72. doi: 10.1378/chest.113.4.968.

  PMID: 9554633 BACKGROUND

• Ram FS, Wedzicha JA, Wright J, Greenstone M. Hospital at home for patients with acute exacerbations of chronic obstructive pulmonary disease: systematic review of evidence. BMJ. 2004 Aug 7;329(7461):315. doi: 10.1136/bmj.38159.650347.55. Epub 2004 Jul 8.

  PMID: 15242868 BACKGROUND

• Bolton CE, Waters CS, Peirce S, Elwyn G; EPSRC and MRC Grand Challenge Team. Insufficient evidence of benefit: a systematic review of home telemonitoring for COPD. J Eval Clin Pract. 2011 Dec;17(6):1216-22. doi: 10.1111/j.1365-2753.2010.01536.x. Epub 2010 Sep 16.

  PMID: 20846317 BACKGROUND

• Gold PM. The 2007 GOLD Guidelines: a comprehensive care framework. Respir Care. 2009 Aug;54(8):1040-9.

  PMID: 19650945 BACKGROUND

• Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.

  PMID: 16055882 BACKGROUND

• Brouwer AF, Visser CA, Duiverman EJ, Roorda RJ, Brand PL. Is home spirometry useful in diagnosing asthma in children with nonspecific respiratory symptoms? Pediatr Pulmonol. 2010 Apr;45(4):326-32. doi: 10.1002/ppul.21183.

  PMID: 20196110 BACKGROUND

• Dellaca RL, Santus P, Aliverti A, Stevenson N, Centanni S, Macklem PT, Pedotti A, Calverley PM. Detection of expiratory flow limitation in COPD using the forced oscillation technique. Eur Respir J. 2004 Feb;23(2):232-40. doi: 10.1183/09031936.04.00046804.

  PMID: 14979497 BACKGROUND

• Dellaca RL, Pompilio PP, Walker PP, Duffy N, Pedotti A, Calverley PM. Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD. Eur Respir J. 2009 Jun;33(6):1329-37. doi: 10.1183/09031936.00139608. Epub 2009 Jan 22.

  PMID: 19164347 BACKGROUND

• Zimmermann SC, Huvanandana J, Nguyen CD, Bertolin A, Watts JC, Gobbi A, Farah CS, Peters MJ, Dellaca RL, King GG, Thamrin C. Day-to-day variability of forced oscillatory mechanics for early detection of acute exacerbations in COPD. Eur Respir J. 2020 Sep 10;56(3):1901739. doi: 10.1183/13993003.01739-2019. Print 2020 Sep.

  PMID: 32430416 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raffaele L Dellaca', PhD

CONTACT

+393804799108; raffaele.dellaca@polimi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 13, 2012
• Study Start: November 1, 2011
• Primary Completion: December 1, 2017
• Study Completion: July 1, 2018
• Last Updated: March 6, 2017

Record last verified: 2017-03

Locations

IT (4); AU (1)