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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04963140
Registration number
NCT04963140
Ethics application status
Date submitted
18/06/2021
Date registered
15/07/2021
Titles & IDs
Public title
Self-Management Of Asthma By Forced Oscillation Technique
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Scientific title
Optimal Self-Management Of Asthma By Forced Oscillation Technique: a Randomised Controlled Trial
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Secondary ID [1]
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1/20
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Universal Trial Number (UTN)
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Trial acronym
PIANOFORTE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Condition category
Condition code
Respiratory
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Optimized self-management of asthma
Other interventions - Conventional self-management of asthma
Experimental: 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
Sham comparator: 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
Other interventions: 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
Other interventions: 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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Asthma Control
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Assessment method [1]
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Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)
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Timepoint [1]
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6 months from enrolment
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Primary outcome [2]
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Symptoms
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Assessment method [2]
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Change of percentage of days with non-increased symptoms from baseline
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Timepoint [2]
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From month no. 2 through study completion, an average of 7 months
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Secondary outcome [1]
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Asthma Control
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Assessment method [1]
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Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)
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Timepoint [1]
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3 months from enrolment
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Secondary outcome [2]
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Asthma Control
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Assessment method [2]
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Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)
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Timepoint [2]
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9 months from enrolment
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Secondary outcome [3]
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Asthma Control
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Assessment method [3]
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Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5) moving from uncontrolled to controlled asthma
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Timepoint [3]
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3 months from enrolment
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Secondary outcome [4]
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Asthma Control
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Assessment method [4]
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Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5) moving from uncontrolled to controlled asthma
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Timepoint [4]
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6 months from enrolment
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Secondary outcome [5]
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Asthma Control
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Assessment method [5]
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Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5) moving from uncontrolled to controlled asthma
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Timepoint [5]
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9 months from enrolment
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Secondary outcome [6]
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Asthma Control
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Assessment method [6]
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Change of percentage of adolescent and adult subjects (12+ years old) who improve their Asthma Control Questionnaire (ACQ-5)
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Timepoint [6]
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3 months from enrolment
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Secondary outcome [7]
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Asthma Control
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Assessment method [7]
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Change of percentage of adolescent and adult subjects (12+ years old) who improve their Asthma Control Questionnaire (ACQ-5)
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Timepoint [7]
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6 months from enrolment
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Secondary outcome [8]
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Asthma Control
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Assessment method [8]
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Change of percentage of adolescent and adult subjects (12+ years old) who improve their Asthma Control Questionnaire (ACQ-5)
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Timepoint [8]
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9 months from enrolment
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Secondary outcome [9]
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Asthma Control
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Assessment method [9]
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Change of mean Asthma Control Questionnaire (ACQ-5); the expected ACQ-5 range is 0 - 3.5, with lower values indicating better asthma outcome
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Timepoint [9]
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3 months from enrolment
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Secondary outcome [10]
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Asthma Control
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Assessment method [10]
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Change of mean Asthma Control Questionnaire (ACQ-5); the expected ACQ-5 range is 0 - 3.5, with lower values indicating better asthma outcome
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Timepoint [10]
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6 months from enrolment
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Secondary outcome [11]
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Asthma Control
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Assessment method [11]
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Change of mean Asthma Control Questionnaire (ACQ-5); the expected ACQ-5 range is 0 - 3.5, with lower values indicating better asthma outcome
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Timepoint [11]
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9 months from enrolment
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Secondary outcome [12]
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Exacerbation
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Assessment method [12]
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Change of number of moderate and severe exacerbations
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Timepoint [12]
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Through study completion, an average of 9 months
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Secondary outcome [13]
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Controller medication usage
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Assessment method [13]
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Change of days with increased controller (inhaled corticosteroid (ICS) alone or in combination with long-acting bronchodilator (LABA))
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Timepoint [13]
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From month no. 2 through study completion, an average of 7 months
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Secondary outcome [14]
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Absence days from school/work
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Assessment method [14]
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Change of absence days from work/school due to asthma
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Timepoint [14]
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Through study completion, an average of 9 months
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Secondary outcome [15]
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Day-to-day variability of respiratory resistance
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Assessment method [15]
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Change of average day-to-day coefficient of variation of inspiratory resistance (CVRinsp)
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Timepoint [15]
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Through study completion, an average of 9 months
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Secondary outcome [16]
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Accuracy of CVRinsp in detecting exacerbations
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Assessment method [16]
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In the control arm of the study only: accuracy, sensitivity and specificity of day-to-day variability of FOT parameters and of related prediction algorithm in identifying the occurrence of future moderate and severe exacerbations
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Timepoint [16]
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Through study completion, an average of 9 months
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Eligibility
Key inclusion criteria
* Age: 6-65 years old
* 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
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Minimum age
6
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Use of oral, rectal or parenteral glucocorticosteroids 30 days before enrolment
* 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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/11/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2024
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Woolcock Institute of Medical Research - Sydney
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Recruitment postcode(s) [1]
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2037 - Sydney
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Recruitment outside Australia
Country [1]
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France
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State/province [1]
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Grenoble
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Country [2]
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France
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State/province [2]
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Nancy
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Country [3]
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Italy
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State/province [3]
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FI
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Country [4]
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Italy
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State/province [4]
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Ancona
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Country [5]
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Italy
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State/province [5]
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Bergamo
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Country [6]
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Italy
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State/province [6]
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Palermo
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Country [7]
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Italy
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State/province [7]
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Pavia
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Country [8]
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Italy
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State/province [8]
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Reggio Emilia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Restech Srl
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Self-management strategies for asthma, including patients engagement and adherence to personalised action plans with advice on recognizing and responding to deterioration in control with effective treatments can improve asthma outcomes and possibly reduce the risk of future exacerbations. However, the real-life evidence is that asthma control remains sub-optimal in the majority of cases, thus increasing the related socio-economic costs worldwide. 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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Trial website
https://clinicaltrials.gov/study/NCT04963140
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Alessandro Gobbi, PhD
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Address
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Country
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Phone
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+390236593690
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
No Individual Participant Data (IPD) sharing planned at this stage
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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/NCT04963140