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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01552031




Registration number
NCT01552031
Ethics application status
Date submitted
6/03/2012
Date registered
13/03/2012
Date last updated
6/03/2017

Titles & IDs
Public title
Monitoring Chronic Obstructive Pulmonary Disease Patients at Home by a Forced Oscillation Technique Device
Scientific title
Monitoring COPD Patients at Home by a Forced Oscillation Technique Device
Secondary ID [1] 0 0
COPD-FOT-MON1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational group -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Every day for 8 months
Primary outcome [2] 0 0
Day-by-day changes of patient's symptom - Changes of perceived symptoms as reported by the patients no the RESMONPRO device
Timepoint [2] 0 0
Every day for 8 months
Primary outcome [3] 0 0
Day-by-day changes of patient activity - level of activity of the patient as recorded by the Actiwatch.
Timepoint [3] 0 0
Every day for 8 months
Primary outcome [4] 0 0
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
Timepoint [4] 0 0
8 months
Primary outcome [5] 0 0
Day-by-day changes of breathing pattern - Changes in breathing pattern measured while performing FOT by RESMONPRO device
Timepoint [5] 0 0
Every day for 8 months

Eligibility
Key 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
Minimum age
40 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Woolcock Institute of Medical Research - Glebe
Recruitment postcode(s) [1] 0 0
2037 - Glebe
Recruitment outside Australia
Country [1] 0 0
Italy
State/province [1] 0 0
BS
Country [2] 0 0
Italy
State/province [2] 0 0
Torino
Country [3] 0 0
Italy
State/province [3] 0 0
Pavia
Country [4] 0 0
Italy
State/province [4] 0 0
Varese

Funding & Sponsors
Primary sponsor type
Other
Name
Raffaele Dellaca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Restech Srl
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Politecnico di Milano
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Fondazione Salvatore Maugeri
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Azienda Ospedaliera S. Luigi, Orbassano (TO)
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Baylor College of Medicine
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Ospedale di Circolo e Fondazione Macchi, Varese
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Woolcock Institute of Medical Research
Address [7] 0 0
Country [7] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01552031
Trial related presentations / publications
United Nations Population Division, World Population Ageing: 1950-2050 2002.
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. Erratum in: Am J Respir Crit Care Med 1997 Jan;155(1):386.
Soler-Cataluña JJ, Martínez-García MA, Román Sánchez 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. Epub 2005 Jul 29.
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. Epub 2009 Jul 20.
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. Erratum in: Thorax. 2008 Aug;63(8):753.
Dal Negro R. Optimizing economic outcomes in the management of COPD. Int J Chron Obstruct Pulmon Dis. 2008;3(1):1-10. Review.
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.
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.
Côté 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.
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. Epub 2004 Jul 8. Review. Erratum in: BMJ. 2004 Oct 2;329(7469):773.
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. Review.
Gold PM. The 2007 GOLD Guidelines: a comprehensive care framework. Respir Care. 2009 Aug;54(8):1040-9. Review. Erratum in: Respir Care. 2009 Nov;54(11):1501.
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.
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.
Dellacà 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.
Dellacà 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.
Public notes

Contacts
Principal investigator
Name 0 0
Raffaele L Dellaca', PhD
Address 0 0
Politecnico di Milano, Italy
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Raffaele L Dellaca', PhD
Address 0 0
Country 0 0
Phone 0 0
+393804799108
Fax 0 0
Email 0 0
raffaele.dellaca@polimi.it
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01552031