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Digital inhaler coach and breathing trainer put to the test against COPD attacks

NCT ID NCT06958666

Disease control Sponsor: Sir Run Run Shaw Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This trial tests whether digital inhaler coaching (DITM) and inspiratory muscle training (IMT), alone or together, can reduce serious flare-ups and hospitalizations in adults with symptomatic, high-risk COPD. Around 410 participants will be split into four groups: DITM, IMT, both, or usual care. Researchers will track exacerbation rates, symptoms, and quality of life over 12 months.

What this could mean

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

Active substance
digital inhaled therapy management and inspiratory muscle training
What this could lead to
If effective, these digital tools and breathing exercises could offer a low-cost, home-based way to reduce dangerous COPD flare-ups and hospital stays.
What could go wrong
This is a single-center trial, and results may not apply to all COPD patients. The interventions require consistent patient engagement, which may be challenging.

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

About 410 people

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

Started

Jun 2025

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

40 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: * Diagnosed as COPD according to "GOLD2024" * Lung function results FEV1/FVC\<60% * Patients with stable COPD who meet one of the following criteria: (A)with CAT score ≥10 or mMRC≥2; (B) ≥2 moderate acute exacerbation or ≥1 hospitalization in the past 12 months * Uses Budesonide MDI (Breztri Aerosphere) or Fluticasone, umeclidinium, and vilanterol (Trelegy Ellipta) or umeclidinium and vilanterol (Anoro Ellipta) as maintenance drug for COPD management * Volunteer to participate in this study and sign the informed consent form. If the subject is unable to read and sign the informed consent form due to incapacity, his/her guardian shall act on his/her behalf to read and sign the informed consent form. Exclusion Criteria: * Unstable angina or severe arrhythmia * Severe weakness-related fatigue, such as in advanced congestive heart failure or chemotherapy-related fatigue * Unstable mental illness with a risk of self-harm or harm to others * Severe cognitive impairment, progressive neuromuscular disease * Pregnant and breastfeeding women * Life expectancy of less than 6 months * Pregnant and breastfeeding women * Inability to cooperate with pulmonary function tests * Inability to complete the entire follow-up period * Vulnerable populations other than the elderly, including individuals with mental illness, cognitive impairment, critically ill patients, illiterate individuals, etc.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease COPD, severe early onset

As listed by the trial registrant

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

COPD, chronic obstructive pulmonary disease

How to take part

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

  1. The places running it

    9 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

  • Department of Respiratory Care, Taizhou Central Hospital

    RECRUITING

    Taizhou, Zhejiang, 318000, China

  • Department of Respiratory and Critical Care Medicine Wenling First People's Hospital

    RECRUITING

    Taizhou, Zhejiang, China

  • Department of Respiratory and Critical Care Medicine, Linhai Second People's Hospital, 198 Dubei Road, Duqiao Town

    RECRUITING

    Taizhou, Zhejiang, 317016, China

  • Jinyun County Hospital of Traditional Chinese Medicine

    RECRUITING

    Lishui, Zhejiang, 321400, China

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310016, China

  • Taizhou Hospital of Zhejiang Province

    RECRUITING

    Taizhou, Zhejiang, 317000, China

  • Taizhou Integrated Traditional Chinese and Western Medicine Hospital

    RECRUITING

    Taizhou, Zhejiang, 317523, China

  • Zhejiang Provincial Hospital of Traditional Chinese Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310006, China

  • Zhejiang Xianju County People's Hospital

    RECRUITING

    Taizhou, Zhejiang, 317399, China

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