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COPD (Chronic Obstructive Pulmonary Disease)NCT06958666

Effectiveness of DITM Versus IMT in COPD Patients

A study testing Digital Inhaled Therapy Management and Inspiratory Muscle Training in people with COPD (Chronic Obstructive Pulmonary Disease), run by Sir Run Run Shaw Hospital at 9 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn if digital inhaled therapy management (DITM) and inspiratory muscle training (IMT), alone or in combination, can improve outcomes in adults aged 40 years and older with symptomatic, high-risk chronic obstructive pulmonary disease (COPD) with moderate to severe airflow… Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Digital Inhaled Therapy Management and Inspiratory Muscle Training
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
410 participants
Where
9 sitesChina
Study dates
30 Jun 2025to May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yiqing Xu, MPH, MSRC contact

+86 13634115344

xuyiqing@srrsh.com

Huiqing Ge, MD contact

+86 13588706787

gehq@zju.edu.cn

9 sites in 1 country

China9 sites, 9 recruiting

  • Zhejiang Provincial Hospital of Traditional Chinese Medicine

    Hangzhou, Zhejiang, 310006

    Fang Chen, 13867130008, funchen@163.com

    Recruiting

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

    Hangzhou, Zhejiang, 310016

    Yiqing Xu, MPH, MSRC, +8613634115344, xuyiqing@srrsh.com

    Huiqing Ge, MD

    Recruiting

  • Jinyun County Hospital of Traditional Chinese Medicine

    Lishui, Zhejiang, 321400

    Li qiu Chen, 13587141120, lcfriendship@163.com

    Recruiting

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, 317000

    You zu Xu, 13626676131, lcfriendship@163.com

    Recruiting

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

    Taizhou, Zhejiang, 317016

    Xiaoli Hu, 13624640498, 752591421@qq.com

    Recruiting

  • Zhejiang Xianju County People's Hospital

    Taizhou, Zhejiang, 317399

    Yang Hua, 13656760886, lcfriendship@163.com

    Recruiting

  • Taizhou Integrated Traditional Chinese and Western Medicine Hospital

    Taizhou, Zhejiang, 317523

    Qifeng Cao, 13958676918, 13958676918@139.com

    Recruiting

  • Department of Respiratory Care, Taizhou Central Hospital

    Taizhou, Zhejiang, 318000

    Junfei Zhu, 13968600802, zhujf@tzzxyy.com

    Recruiting

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

    Taizhou, Zhejiang

    Aiguo Jiang, 18858658383, 240093181@qq.com

    Recruiting

Other trials in China

About this study

Official title: Effectiveness of DITM Versus IMT in COPD Patients With High Symptom Burden and High Risk of Acute Exacerbation: A Randomized Controlled Study

The goal of this clinical trial is to learn if digital inhaled therapy management (DITM) and inspiratory muscle training (IMT), alone or in combination, can improve outcomes in adults aged 40 years and older with symptomatic, high-risk chronic obstructive pulmonary disease (COPD) with moderate to severe airflow limitation (FEV1/FVC < 60%). The main questions it aims to answer are:

Does DITM reduce the rate of moderate to severe COPD exacerbations and hospitalizations compared to usual care? Does IMT reduce the rate of moderate to severe COPD exacerbations and hospitalizations compared to usual care? Does the combination of DITM and IMT reduce the rate of moderate to severe COPD exacerbations and hospitalizations compared to usual care? What are the effects of DITM, IMT, and their combination on the time to first moderate to severe exacerbation, COPD Assessment Test (CAT) score, modified Medical Research Council (mMRC) score, and St. George's Respiratory Questionnaire for chronic obstructive pulmonary disease (SGRQ-C) score? Researchers will compare four groups: a DITM group, an IMT group, a DITM+IMT group, and a control group receiving usual care, to see if these interventions improve outcomes related to COPD exacerbations, symptoms, quality of life, and inspiratory muscle strength.

Read more

Participants will:

DITM Group: Receive training on inhaler technique using a digital device and use a digital sensor with a mobile app for home-based inhalation management, including reminders and feedback.

IMT Group: Receive verbal inhaler technique training and use a breathing trainer with accompanying software for inspiratory muscle training.

DITM+IMT Group: Receive both the digital inhalation management and inspiratory muscle training interventions.

Control Group: Receive verbal inhaler technique training only. All participants will undergo baseline assessments and follow-up assessments at 3, 6, and 12 months, including questionnaires, lung function tests, respiratory muscle strength measurements, and a 6-minute walk test. They will also report on any COPD exacerbations experienced during the study period.

Being tested
Digital Inhaled Therapy Management, Inspiratory Muscle Training
Keywords
Pulmonary Rehabilitation, COPD, GOLD2024, Global Initiative for Chronic Obstructive Lung Disease, Digital Inhaled Therapy Management, Inspiratory Muscle Training
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital Inhaled Therapy ManagementDevice

    The subjects will be trained on their inhalation techniques with the "Digital Medication Administration Device" consists of an inhalation device with a display and inhalation technique assessment module. The device will show a standardized video demonstration and will evaluate the subjects' inhalation technique. A printed report will be available afterwards.

    A home-based inhalation management service package will be provided to the subjects including a digital sensor that records the time, frequency, and key inhalation technique parameters for each use of metered-dose inhalers or dry powder inhalers, and automatically synchronizes the data to the cloud. The data is then analyzed for adherence and technique performance. Based on the data, subjects will receive medication reminders and voice alerts for any technique errors on the app provided with the package. Visual charts of medication adherence and inhalation technique will be available to reinforce self-management.

  • Inspiratory Muscle TrainingDevice

    The subjects will receive standardized verbal training and demonstration of inhalation techniques and any questions will be answered Inspiratory muscle training equipment, ancillary software, inspiratory muscle training plan, and equipment user guide will be sent home with the patient.

Study groups in NCT06958666
Study groupRoleWhat they receive
Digital Inhalation Management GroupExperimentalDigital Inhalation Management Group will receive digital inhaled therapy management only
Receives: Device: Digital Inhaled Therapy Management
Inspiratory Muscle Training GroupExperimentalInspiratory Muscle Training Group will receive inspiratory muscle training only
Receives: Device: Inspiratory Muscle Training
Inhalation Muscle Training Combined with Digital Inhalation Therapy Management GroupExperimentalThe subjects will receive Inspiratory muscle training equipment, ancillary software, inspiratory muscle training plan, and equipment user guide in addition to training on the use of Digital Inhalation Administration device.
Receives: Device: Digital Inhaled Therapy Management; Device: Inspiratory Muscle Training
Compare GroupNo interventionThe subjects will receive standardized verbal training and demonstration of inhalation techniques. No additional equipment provided

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of acute exacerbation of moderate-to-severe COPD and hospitalization during follow-up period

    Rate of acute exacerbation of moderate-to-severe COPD and hospitalization during follow-up period will be accessed as the primary endpoint. Acute exacerbation of COPD is defined according to the "Chinese Expert Consensus on the Diagnosis and Treatment of Acute Exacerbation of COPD" 2023 version.

    Measured: Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training

Secondary outcomes (4)

  1. Days to first Moderate-to-Severe Acute Exacerbation

    Time from baseline to the occurrence of the first acute exacerbation in days.

    Measured: Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training

  2. COPD Assessment Test (CAT) Score

    Self-reported measure of health status in COPD patients, assessed using the CAT questionnaire. Higher scores indicate a greater impact of COPD on daily life.

    Measured: Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training

  3. Modified Medical Research Council (mMRC) Dyspnea Score

    Patient-rated scale assessing the severity of breathlessness. Higher grade indicates higher severity.

    Measured: Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training

  4. St. George's Respiratory Questionnaire (SGRQ) Score

    Quality of life assessment specific to respiratory diseases. Higher scores reflect worse health-related quality of life.

    Measured: assessed only during the last two follow ups (6 months and 12 months).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2025
  2. Study start30 Jun 2025
  3. Primary completionMay 2028 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

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
None (open label)
Enrolment
410 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06958666
Sponsor's protocol ID
20250119
Status last verified
Jul 2025
First submitted
16 Apr 2025
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Molimard M, Raherison C, Lignot S, Balestra A, Lamarque S, Chartier A, Droz-Perroteau C, Lassalle R, Moore N, Girodet PO. Chronic obstructive pulmonary disease exacerbation and inhaler device handling: real-life assessment of 2935 patients. Eur Respir J. 2017 Feb 15;49(2):1601794. doi: 10.1183/13993003.01794-2016. Print 2017 Feb.

    PubMed 28182569

  • Melani AS, Bonavia M, Cilenti V, Cinti C, Lodi M, Martucci P, Serra M, Scichilone N, Sestini P, Aliani M, Neri M; Gruppo Educazionale Associazione Italiana Pneumologi Ospedalieri. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir Med. 2011 Jun;105(6):930-8. doi: 10.1016/j.rmed.2011.01.005. Epub 2011 Mar 2.

    PubMed 21367593

  • Molimard M, Raherison C, Lignot S, Depont F, Abouelfath A, Moore N. Assessment of handling of inhaler devices in real life: an observational study in 3811 patients in primary care. J Aerosol Med. 2003 Fall;16(3):249-54. doi: 10.1089/089426803769017613.

    PubMed 14572322

  • Cho-Reyes S, Celli BR, Dembek C, Yeh K, Navaie M. Inhalation Technique Errors with Metered-Dose Inhalers Among Patients with Obstructive Lung Diseases: A Systematic Review and Meta-Analysis of U.S. Studies. Chronic Obstr Pulm Dis. 2019 Jul 24;6(3):267-280. doi: 10.15326/jcopdf.6.3.2018.0168.

    PubMed 31342732

  • Sanchis J, Gich I, Pedersen S; Aerosol Drug Management Improvement Team (ADMIT). Systematic Review of Errors in Inhaler Use: Has Patient Technique Improved Over Time? Chest. 2016 Aug;150(2):394-406. doi: 10.1016/j.chest.2016.03.041. Epub 2016 Apr 7.

    PubMed 27060726

  • Crompton GK, Barnes PJ, Broeders M, Corrigan C, Corbetta L, Dekhuijzen R, Dubus JC, Magnan A, Massone F, Sanchis J, Viejo JL, Voshaar T; Aerosol Drug Management Improvement Team. The need to improve inhalation technique in Europe: a report from the Aerosol Drug Management Improvement Team. Respir Med. 2006 Sep;100(9):1479-94. doi: 10.1016/j.rmed.2006.01.008. Epub 2006 Feb 21.

    PubMed 16495040

  • Souza ML, Meneghini AC, Ferraz E, Vianna EO, Borges MC. Knowledge of and technique for using inhalation devices among asthma patients and COPD patients. J Bras Pneumol. 2009 Sep;35(9):824-31. doi: 10.1590/s1806-37132009000900002. English, Portuguese.

    PubMed 19820807

  • Raissy HH, Kelly HW, Harkins M, Szefler SJ. Inhaled corticosteroids in lung diseases. Am J Respir Crit Care Med. 2013 Apr 15;187(8):798-803. doi: 10.1164/rccm.201210-1853PP.

    PubMed 23370915

  • Chen S, Kuhn M, Prettner K, Yu F, Yang T, Barnighausen T, Bloom DE, Wang C. The global economic burden of chronic obstructive pulmonary disease for 204 countries and territories in 2020-50: a health-augmented macroeconomic modelling study. Lancet Glob Health. 2023 Aug;11(8):e1183-e1193. doi: 10.1016/S2214-109X(23)00217-6.

    PubMed 37474226

  • Meghji J, Mortimer K, Agusti A, Allwood BW, Asher I, Bateman ED, Bissell K, Bolton CE, Bush A, Celli B, Chiang CY, Cruz AA, Dinh-Xuan AT, El Sony A, Fong KM, Fujiwara PI, Gaga M, Garcia-Marcos L, Halpin DMG, Hurst JR, Jayasooriya S, Kumar A, Lopez-Varela MV, Masekela R, Mbatchou Ngahane BH, Montes de Oca M, Pearce N, Reddel HK, Salvi S, Singh SJ, Varghese C, Vogelmeier CF, Walker P, Zar HJ, Marks GB. Improving lung health in low-income and middle-income countries: from challenges to solutions. Lancet. 2021 Mar 6;397(10277):928-940. doi: 10.1016/S0140-6736(21)00458-X. Epub 2021 Feb 22.

    PubMed 33631128

  • Zhou M, Wang H, Zeng X, Yin P, Zhu J, Chen W, Li X, Wang L, Wang L, Liu Y, Liu J, Zhang M, Qi J, Yu S, Afshin A, Gakidou E, Glenn S, Krish VS, Miller-Petrie MK, Mountjoy-Venning WC, Mullany EC, Redford SB, Liu H, Naghavi M, Hay SI, Wang L, Murray CJL, Liang X. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 Sep 28;394(10204):1145-1158. doi: 10.1016/S0140-6736(19)30427-1. Epub 2019 Jun 24.

    PubMed 31248666

  • Wang C, Xu J, Yang L, Xu Y, Zhang X, Bai C, Kang J, Ran P, Shen H, Wen F, Huang K, Yao W, Sun T, Shan G, Yang T, Lin Y, Wu S, Zhu J, Wang R, Shi Z, Zhao J, Ye X, Song Y, Wang Q, Zhou Y, Ding L, Yang T, Chen Y, Guo Y, Xiao F, Lu Y, Peng X, Zhang B, Xiao D, Chen CS, Wang Z, Zhang H, Bu X, Zhang X, An L, Zhang S, Cao Z, Zhan Q, Yang Y, Cao B, Dai H, Liang L, He J; China Pulmonary Health Study Group. Prevalence and risk factors of chronic obstructive pulmonary disease in China (the China Pulmonary Health [CPH] study): a national cross-sectional study. Lancet. 2018 Apr 28;391(10131):1706-1717. doi: 10.1016/S0140-6736(18)30841-9. Epub 2018 Apr 9.

    PubMed 29650248

  • Xu Y, Zhou M, Hu X, Pan L, Chen F, Chen B, Cao Q, Jiang T, Zhu J, Li N, Jiang A, Lian C, Chen Z, Ge H. Effectiveness of digital inhaled therapy management and respiratory muscle training in moderate to severe COPD patients: study protocol for a randomized controlled, assessor-blinded, multicenter trial. Trials. 2026 Jun 5;27(1):431. doi: 10.1186/s13063-026-09822-0.

    PubMed 42243883

Questions about this trial

What is this clinical trial studying?

A study testing Digital Inhaled Therapy Management and Inspiratory Muscle Training in people with COPD (Chronic Obstructive Pulmonary Disease), run by Sir Run Run Shaw Hospital at 9 sites in China.

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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 24 Jul 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 China. 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. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yiqing Xu, MPH, MSRC (+86 13634115344, xuyiqing@srrsh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of acute exacerbation of moderate-to-severe COPD and hospitalization during follow-up period (time frame: Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06958666, which also lists 13 linked publications.

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 24 Jul 2026.

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