Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Timepoint [1] 0 0
Every day for 8 months
Primary outcome [2] 0 0
Day-by-day changes of patient's symptom
Timepoint [2] 0 0
Every day for 8 months
Primary outcome [3] 0 0
Day-by-day changes of patient activity
Timepoint [3] 0 0
Every day for 8 months
Primary outcome [4] 0 0
Number of exacerbation
Timepoint [4] 0 0
8 months
Primary outcome [5] 0 0
Day-by-day changes of breathing pattern
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
Sex
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
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2018
Actual
Sample size
Target
80
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
Trial website
Trial related presentations / publications
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
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01552031