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Smart inhaler gadget aims to tame tough asthma

NCT ID NCT06908421

Disease control Sponsor: Chiesi Pharma AB, Nordic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study is testing whether a smart inhaler cap and mobile app can help adults with poorly controlled asthma use their inhaler correctly and take their medication as prescribed. Sixty participants will use the smart system for one year while continuing their usual asthma treatment. Researchers will track changes in airway inflammation, asthma control, and inhaler technique to see if the technology makes a difference.

What this could mean

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

Active substance
Trimbow pMDI (a single-inhaler triple therapy with an inhaled corticosteroid, a long-acting beta-agonist, and a long-acting muscarinic antagonist)
What this could lead to
If it works, this could show that a smart platform helps people with asthma use their inhaler correctly and stick to their medication, leading to better asthma control and fewer flare-ups.
What could go wrong
This is a small, early observational study with only 60 participants and no comparison group, so results may not apply to everyone. It also relies on people consistently using the app and smart cap, which may not happen in real life.

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.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

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.

Who is studied

Asthma patients above 18 years of age, with objectively verified diagnosis of asthma according to GINA, uncontrolled T2 inflammation (FeNO \>25ppm) on BDP/FF/G inhalation treatment with prescribed rescue medication (SABA).

Ages

18 years and older

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: 1. Patients ≥18 years of age. 2. Objectively verified leading diagnosis of asthma according to GINA 3. FeNO \>25 ppb. 4. Treated with Trimbow 87/5/9 pMDI for \>4 weeks before enrolment, 1. with prescribed rescue medication (SABA). 2. with and without prescription of a spacer. 5. Being literate Danish. 6. Having a personal Android/iOS phone and 4G/5G internet connection. 7. Comfortable using a smart phone and Bluetooth enabled Digital Devices. 8. Willingness to participate in the study, understand the written patient information and being able to provide written informed consent. Exclusion Criteria: 1. Participation in a clinical trial within 4 weeks prior to enrolment into the present study or planned enrolment in a clinical trial during the observational period. 2. Use of systemic corticosteroid as maintenance treatment. 3. Treated with biologics (that is monoclonal antibodies). 4. Concomitant diagnosis of COPD. 5. Lung cancer or history of lung cancer. 6. Respiratory tract infection/exacerbation within 4 weeks prior to enrolment. 7. Use of oral corticosteroids within 4 weeks before enrolment.

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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

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

Asthma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aarhus University Hospital

    RECRUITING

    Aarhus, Central Jutland, DK-8200 Aarhus N, Denmark

  • Copenhagen University Hospital-Hvidovre

    RECRUITING

    Hvidovre, Capital Region, DK-2650, Denmark

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