Self-Management Of Asthma By Forced Oscillation Technique
NCT ID: NCT04963140
Last Updated: 2023-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2020-11-16
2024-09-30
Brief Summary
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Because an increased variability of lung function remains a hallmark of poor asthma control and exacerbations, its assessment over time could contribute to the success of self-management plans. Previous studies have shown the potential of Forced Oscillation Technique (FOT) as a tool for monitoring increased variability of airway obstruction and for identifying the onset of acute deterioration of airway function.
The aim of this study is to test the hypothesis that a personalised self-management plan including FOT improves asthma control and reduces number of days with increased symptoms compared to conventional asthma treatment.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Intervention
Intervention subjects will monitor their lung function daily by Forced Oscillation Technique (FOT) device. The embedded algorithm signals when an increased risk of exacerbation is detected and subjects shall modify their treatment based on the action plan prescribed by the study doctor at enrolment and used for the self-management of their asthma
Optimized self-management of asthma
Short-term increase of asthma medication (as prescribed by the study doctor at enrolment) if an increased risk of asthma exacerbations is detected by the home monitoring device
Control
Control subjects will monitor their lung function daily by Forced Oscillation Technique (FOT) device. The embedded algorithm used in the intervention arm is disabled. Subjects will follow the action plan prescribed by the study doctor at enrolment for the self-management of their asthma
Conventional self-management of asthma
Short-term increase of asthma medication (as prescribed by the study doctor at enrolment) is based on subject's self-perception of symptoms
Interventions
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Optimized self-management of asthma
Short-term increase of asthma medication (as prescribed by the study doctor at enrolment) if an increased risk of asthma exacerbations is detected by the home monitoring device
Conventional self-management of asthma
Short-term increase of asthma medication (as prescribed by the study doctor at enrolment) is based on subject's self-perception of symptoms
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of persistent asthma
* Treatment level at study entry:
* For children 6-11 years: Step2 or Step3 of the GINA document
* For adolescents and adults 12-65 years: Step2 under daily low-dose inhaled corticosteroids (ICS), Step 3 or Step 4 of the GINA document
* Uncontrolled asthma (ACQ-5 \> 1.5) that, according to the physician, does not warrant an immediate step-up of the treatment
* History of moderate or severe exacerbations in the twelve (12) months prior to baseline visit
Exclusion Criteria
* Treatment with leukotriene receptor antagonist (LTRA)
* Treatment with maintenance and reliever therapy (SMART/MART)
* Smoking, current or previous with a history of 10 pack-years or more
* Documented COPD or other concomitant clinically important diseases or cognitive impairment that, according to the physician, may interfere with the subject's ability or safety to participate in the study
* Obesity (for subjects 6-19 years: BMI ≥ 95th percentile; for adults 20-65 years: BMI ≥ 40kg⋅m-2
* For school-age children (6-11 years old): gestational age at birth \< 37 weeks or documented bronchopulmonary dysplasia (BPD)
* Prolonged absence from home during the monitoring period (i.e. at recruitment, expected ≥3 consecutive weeks for ≥2 times during the 9- month monitoring period) Subject currently enrolled in other clinical trials related or involving the study of the respiratory system
* History of near-fatal asthma
* Women who are pregnant, nursing or intending to become pregnant during the time of the study
* Absence of health insurance coverage (applies to French centres only)
6 Years
65 Years
ALL
No
Sponsors
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Restech Srl
INDUSTRY
Responsible Party
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Locations
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Woolcock Institute of Medical Research
Sydney, , Australia
Grenoble University Hospital
Grenoble, , France
University Children's Hospital of Nancy
Nancy, , France
Azienda Ospedaliero, Universitaria Meyer
Florence, FI, Italy
AOU Ospedali Riuniti Ancona
Ancona, , Italy
ASST Papa Giovanni XXIII
Bergamo, , Italy
Istituto di Farmacologia Traslazionale (IFT) del CNR
Palermo, , Italy
Istituto di Farmacologia Traslazionale (IFT) del CNR
Palermo, , Italy
Fondazione IRCCS Policlinico S. Matteo
Pavia, , Italy
Azienda Unità Sanitaria Locale di Reggio Emilia
Reggio Emilia, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1/20
Identifier Type: -
Identifier Source: org_study_id
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