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Could a smart lung monitor outsmart asthma symptoms?

NCT ID NCT04963140

Disease control Sponsor: Restech Srl Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This trial tests whether a personalized asthma action plan guided by a home monitoring device—using Forced Oscillation Technique (FOT) to measure lung function—can improve asthma control better than the usual approach of adjusting medication based on how symptoms feel. People aged 6 to 65 with persistent but uncontrolled asthma will use the device to detect early signs of worsening airway function and adjust their prescribed medication accordingly. The study compares this device-guided strategy to conventional symptom-based self-management, looking at changes in asthma control and the number of days with increased symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A personalized asthma self-management plan guided by a home monitoring device using Forced Oscillation Technique (FOT) to detect early signs of worsening lung function.
What this could lead to
If effective, this approach could help people with asthma better control their condition and reduce symptom days, potentially lowering the risk of severe attacks.
What could go wrong
This is a small, early-stage trial, and the device-based approach may not prove more effective than standard symptom-based management. It also requires consistent home monitoring, which may not suit everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

39 people

The number who actually took part.

Started

Nov 2020

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

asthma chronic asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

Contacts and locations

Locations

  • AOU Ospedali Riuniti Ancona

    Ancona, 60126, Italy

  • ASST Papa Giovanni XXIII

    Bergamo, 24127, Italy

  • Azienda Ospedaliero, Universitaria Meyer

    Florence, FI, 50139, Italy

  • Azienda Unità Sanitaria Locale di Reggio Emilia

    Reggio Emilia, 42124, Italy

  • Fondazione IRCCS Policlinico S. Matteo

    Pavia, 27100, Italy

  • Grenoble University Hospital

    Grenoble, 38043, France

  • Istituto di Farmacologia Traslazionale (IFT) del CNR

    Palermo, 90146, Italy

  • University Children's Hospital of Nancy

    Nancy, 54500, France

  • Woolcock Institute of Medical Research

    Sydney, 2037, Australia

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