AsthmaPIANOFORTENCT04963140
Self-Management Of Asthma By Forced Oscillation Technique
A study testing Optimized self-management of asthma and Conventional self-management of asthma in people with Asthma, run by Restech Srl at 9 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Optimized self-management of asthma and Conventional self-management of asthma
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 16 Nov 2020to 24 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Italy6 sites
AOU Ospedali Riuniti Ancona
Ancona, 60126
ASST Papa Giovanni XXIII
Bergamo, 24127
Azienda Ospedaliero, Universitaria Meyer
Florence, FI, 50139
Istituto di Farmacologia Traslazionale (IFT) del CNR
Palermo, 90146
Fondazione IRCCS Policlinico S. Matteo
Pavia, 27100
Azienda Unità Sanitaria Locale di Reggio Emilia
Reggio Emilia, 42124
France2 sites
Grenoble University Hospital
Grenoble, 38043
University Children's Hospital of Nancy
Nancy, 54500
About this study
Official title: Optimal Self-Management Of Asthma By Forced Oscillation Technique: a Randomised Controlled Trial
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.
- Conditions
- Asthma
- Being tested
- Optimized self-management of asthma, Conventional self-management of asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimized self-management of asthmaOther
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 asthmaOther
Short-term increase of asthma medication (as prescribed by the study doctor at enrolment) is based on subject's self-perception of symptoms
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 Receives: Other: Optimized self-management of asthma |
| Control | Sham comparator | 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 Receives: Other: Conventional self-management of asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)
Measured: 6 months from enrolment
Symptoms
Change of percentage of days with non-increased symptoms from baseline
Measured: From month no. 2 through study completion, an average of 7 months
Secondary outcomes (16)
Asthma Control
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)
Measured: 3 months from enrolment
Asthma Control
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)
Measured: 9 months from enrolment
Asthma Control
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5) moving from uncontrolled to controlled asthma
Measured: 3 months from enrolment
Asthma Control
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5) moving from uncontrolled to controlled asthma
Measured: 6 months from enrolment
Asthma Control
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5) moving from uncontrolled to controlled asthma
Measured: 9 months from enrolment
Asthma Control
Change of percentage of adolescent and adult subjects (12+ years old) who improve their Asthma Control Questionnaire (ACQ-5)
Measured: 3 months from enrolment
Asthma Control
Change of percentage of adolescent and adult subjects (12+ years old) who improve their Asthma Control Questionnaire (ACQ-5)
Measured: 6 months from enrolment
Asthma Control
Change of percentage of adolescent and adult subjects (12+ years old) who improve their Asthma Control Questionnaire (ACQ-5)
Measured: 9 months from enrolment
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
Measured: 3 months from enrolment
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
Measured: 6 months from enrolment
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
Measured: 9 months from enrolment
Exacerbation
Change of number of moderate and severe exacerbations
Measured: Through study completion, an average of 9 months
Controller medication usage
Change of days with increased controller (inhaled corticosteroid (ICS) alone or in combination with long-acting bronchodilator (LABA))
Measured: From month no. 2 through study completion, an average of 7 months
Absence days from school/work
Change of absence days from work/school due to asthma
Measured: Through study completion, an average of 9 months
Day-to-day variability of respiratory resistance
Change of average day-to-day coefficient of variation of inspiratory resistance (CVRinsp)
Measured: Through study completion, an average of 9 months
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
Measured: Through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start16 Nov 2020
- Primary completion24 Apr 2024
- Study completion24 Sep 2024
Why it stopped: The study was terminated early due to an unexpected difficulty at the study sites in recruiting patients who met all the inclusion criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Restech Srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963140
- Sponsor's protocol ID
- 1/20
- Acronym
- PIANOFORTE
- Status last verified
- Aug 2026
- First submitted
- 18 Jun 2021
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No Individual Participant Data (IPD) sharing planned at this stage
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Self-Management Of Asthma By Forced Oscillation Technique: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04963140
- Acronym / sponsor ID
- PIANOFORTE / 1/20
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to an unexpected difficulty at the study sites in recruiting patients who met all the inclusion criteria.
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Restech SrlIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 24 Sep 2024 (actual)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Optimized self-management of asthmaIntervention 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 | Sham comparator | Other: Conventional self-management of asthmaControl 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 |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 6-65 years old
- Diagnosis of persistent asthma
- Treatment level at study entry:
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimized self-management of asthmaShort-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 | Intervention |
| Conventional self-management of asthmaShort-term increase of asthma medication (as prescribed by the study doctor at enrolment) is based on subject's self-perception of symptoms | Other | Control |
Primary outcome
Asthma Control
Time frame: 6 months from enrolment
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)
Symptoms
Time frame: From month no. 2 through study completion, an average of 7 months
Change of percentage of days with non-increased symptoms from baseline
16 secondary outcomes
Asthma Control
Time frame: 3 months from enrolment
Asthma Control
Time frame: 9 months from enrolment
Asthma Control
Time frame: 3 months from enrolment
Asthma Control
Time frame: 6 months from enrolment
Asthma Control
Time frame: 9 months from enrolment
Asthma Control
Time frame: 3 months from enrolment
Asthma Control
Time frame: 6 months from enrolment
Asthma Control
Time frame: 9 months from enrolment
Asthma Control
Time frame: 3 months from enrolment
Asthma Control
Time frame: 6 months from enrolment
Asthma Control
Time frame: 9 months from enrolment
Exacerbation
Time frame: Through study completion, an average of 9 months
Controller medication usage
Time frame: From month no. 2 through study completion, an average of 7 months
Absence days from school/work
Time frame: Through study completion, an average of 9 months
Day-to-day variability of respiratory resistance
Time frame: Through study completion, an average of 9 months
Accuracy of CVRinsp in detecting exacerbations
Time frame: Through study completion, an average of 9 months
Results and safety
The study was stopped early (reason given: The study was terminated early due to an unexpected difficulty at the study sites in recruiting patients who met all the inclusion criteria.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No. No Individual Participant Data (IPD) sharing planned at this stage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimized self-management of asthma and Conventional self-management of asthma in people with Asthma, run by Restech Srl at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy, France, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated early due to an unexpected difficulty at the study sites in recruiting patients who met all the inclusion criteria.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control (time frame: 6 months from enrolment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.