Back to resultsSelf-Management Of Asthma By Forced Oscillation Technique (PIANOFORTE)
Primary Purpose
Asthma
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Optimized self-management of asthma
Conventional self-management of asthma
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
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
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)
Sites / Locations
- Woolcock Institute of Medical Research
- Grenoble University HospitalRecruiting
- University Children's Hospital of NancyRecruiting
- Azienda Ospedaliero, Universitaria MeyerRecruiting
- AOU Ospedali Riuniti AnconaRecruiting
- ASST Papa Giovanni XXIIIRecruiting
- Istituto di Farmacologia Traslazionale (IFT) del CNR
- Istituto di Farmacologia Traslazionale (IFT) del CNR
- Fondazione IRCCS Policlinico S. MatteoRecruiting
- Azienda Unità Sanitaria Locale di Reggio EmiliaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Intervention
Control
Arm Description
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
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
Outcomes
Primary Outcome Measures
Asthma Control
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)
Symptoms
Change of percentage of days with non-increased symptoms from baseline
Secondary Outcome Measures
Asthma Control
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)
Asthma Control
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)
Asthma Control
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5) moving from uncontrolled to controlled asthma
Asthma Control
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5) moving from uncontrolled to controlled asthma
Asthma Control
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5) moving from uncontrolled to controlled asthma
Asthma Control
Change of percentage of adolescent and adult subjects (12+ years old) who improve their Asthma Control Questionnaire (ACQ-5)
Asthma Control
Change of percentage of adolescent and adult subjects (12+ years old) who improve their Asthma Control Questionnaire (ACQ-5)
Asthma Control
Change of percentage of adolescent and adult subjects (12+ years old) who improve their Asthma Control Questionnaire (ACQ-5)
Asthma Control
Change of mean Asthma Control Questionnaire (ACQ-5); the expected ACQ-5 range is 0 - 3.5, with lower values indicating better asthma outcome
Asthma Control
Change of mean Asthma Control Questionnaire (ACQ-5); the expected ACQ-5 range is 0 - 3.5, with lower values indicating better asthma outcome
Asthma Control
Change of mean Asthma Control Questionnaire (ACQ-5); the expected ACQ-5 range is 0 - 3.5, with lower values indicating better asthma outcome
Exacerbation
Change of number of moderate and severe exacerbations
Controller medication usage
Change of days with increased controller (inhaled corticosteroid (ICS) alone or in combination with long-acting bronchodilator (LABA))
Absence days from school/work
Change of absence days from work/school due to asthma
Day-to-day variability of respiratory resistance
Change of average day-to-day coefficient of variation of inspiratory resistance (CVRinsp)
Accuracy of CVRinsp in detecting exacerbations
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04963140
Brief Title
Self-Management Of Asthma By Forced Oscillation Technique
Acronym
PIANOFORTE
Official Title
Optimal Self-Management Of Asthma By Forced Oscillation Technique: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2020 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Restech Srl
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Optimized self-management of asthma
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Conventional self-management of asthma
Intervention Description
Short-term increase of asthma medication (as prescribed by the study doctor at enrolment) is based on subject's self-perception of symptoms
Primary Outcome Measure Information:
Title
Asthma Control
Description
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)
Time Frame
6 months from enrolment
Title
Symptoms
Description
Change of percentage of days with non-increased symptoms from baseline
Time Frame
From month no. 2 through study completion, an average of 7 months
Secondary Outcome Measure Information:
Title
Asthma Control
Description
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)
Time Frame
3 months from enrolment
Title
Asthma Control
Description
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)
Time Frame
9 months from enrolment
Title
Asthma Control
Description
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5) moving from uncontrolled to controlled asthma
Time Frame
3 months from enrolment
Title
Asthma Control
Description
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5) moving from uncontrolled to controlled asthma
Time Frame
6 months from enrolment
Title
Asthma Control
Description
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5) moving from uncontrolled to controlled asthma
Time Frame
9 months from enrolment
Title
Asthma Control
Description
Change of percentage of adolescent and adult subjects (12+ years old) who improve their Asthma Control Questionnaire (ACQ-5)
Time Frame
3 months from enrolment
Title
Asthma Control
Description
Change of percentage of adolescent and adult subjects (12+ years old) who improve their Asthma Control Questionnaire (ACQ-5)
Time Frame
6 months from enrolment
Title
Asthma Control
Description
Change of percentage of adolescent and adult subjects (12+ years old) who improve their Asthma Control Questionnaire (ACQ-5)
Time Frame
9 months from enrolment
Title
Asthma Control
Description
Change of mean Asthma Control Questionnaire (ACQ-5); the expected ACQ-5 range is 0 - 3.5, with lower values indicating better asthma outcome
Time Frame
3 months from enrolment
Title
Asthma Control
Description
Change of mean Asthma Control Questionnaire (ACQ-5); the expected ACQ-5 range is 0 - 3.5, with lower values indicating better asthma outcome
Time Frame
6 months from enrolment
Title
Asthma Control
Description
Change of mean Asthma Control Questionnaire (ACQ-5); the expected ACQ-5 range is 0 - 3.5, with lower values indicating better asthma outcome
Time Frame
9 months from enrolment
Title
Exacerbation
Description
Change of number of moderate and severe exacerbations
Time Frame
Through study completion, an average of 9 months
Title
Controller medication usage
Description
Change of days with increased controller (inhaled corticosteroid (ICS) alone or in combination with long-acting bronchodilator (LABA))
Time Frame
From month no. 2 through study completion, an average of 7 months
Title
Absence days from school/work
Description
Change of absence days from work/school due to asthma
Time Frame
Through study completion, an average of 9 months
Title
Day-to-day variability of respiratory resistance
Description
Change of average day-to-day coefficient of variation of inspiratory resistance (CVRinsp)
Time Frame
Through study completion, an average of 9 months
Title
Accuracy of CVRinsp in detecting exacerbations
Description
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
Time Frame
Through study completion, an average of 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandro Gobbi, PhD
Phone
+390236593690
Email
a.gobbi@restech.it
First Name & Middle Initial & Last Name or Official Title & Degree
Pasquale Pio Pompilio, PhD
Phone
+390236593690
Email
p.pompilio@restech.it
Facility Information:
Facility Name
Woolcock Institute of Medical Research
City
Sydney
ZIP/Postal Code
2037
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory King
Email
gregory.king@sydney.edu.au
Facility Name
Grenoble University Hospital
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sam Bayat
Email
sbayat@chu-grenoble.fr
Facility Name
University Children's Hospital of Nancy
City
Nancy
ZIP/Postal Code
54500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iulia Cristina Ioan
Email
ic.ioan@chru-nancy.fr
Facility Name
Azienda Ospedaliero, Universitaria Meyer
City
Firenze
State/Province
FI
ZIP/Postal Code
50139
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrico Lombardi
Email
enrico.lombardi@meyer.it
Facility Name
AOU Ospedali Riuniti Ancona
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Beatrice Bilo'
Email
mariabeatrice.bilo@ospedaliriuniti.marche.it
Facility Name
ASST Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gianluca Imeri, Dr
Email
gimeri@asst-pg23.it
Facility Name
Istituto di Farmacologia Traslazionale (IFT) del CNR
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefania La Grutta
Email
stefania.lagrutta@ift.cnr.it
Facility Name
Istituto di Farmacologia Traslazionale (IFT) del CNR
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppina Cuttitta
Email
giuseppina.cuttitta@ift.cnr.it
Facility Name
Fondazione IRCCS Policlinico S. Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelo Corsico
Email
corsico@unipv.it
Facility Name
Azienda Unità Sanitaria Locale di Reggio Emilia
City
Reggio Emilia
ZIP/Postal Code
42124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chiara Scelfo
Email
chiara.scelfo@ausl.re.it
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No Individual Participant Data (IPD) sharing planned at this stage
Learn more about this trial
Self-Management Of Asthma By Forced Oscillation Technique
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