Effectiveness of DITM Versus IMT in COPD Patients

Official title

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

Overview

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. 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.

Interventions

• Device Digital Inhaled Therapy Management
  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, freq
• Device Inspiratory Muscle Training
  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.

Primary outcome measures

• 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]

Secondary outcome measures (4)

• Days to first Moderate-to-Severe Acute Exacerbation [Time frame: Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training]
• COPD Assessment Test (CAT) Score [Time frame: Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training]
• Modified Medical Research Council (mMRC) Dyspnea Score [Time frame: Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training]
• St. George's Respiratory Questionnaire (SGRQ) Score [Time frame: assessed only during the last two follow ups (6 months and 12 months).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 9 centers

• Zhejiang Provincial Hospital of Traditional Chinese Medicine — Hangzhou
• Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Hangzhou
• Jinyun County Hospital of Traditional Chinese Medicine — Lishui
• Taizhou Hospital of Zhejiang Province — Taizhou
• Department of Respiratory and Critical Care Medicine, Linhai Second People's Hospital, 198 — Taizhou
• Zhejiang Xianju County People's Hospital — Taizhou
• Taizhou Integrated Traditional Chinese and Western Medicine Hospital — Taizhou
• Department of Respiratory Care, Taizhou Central Hospital — Taizhou
• … and 1 more center

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 23370915

Identifiers

NCT: NCT06958666 · 20250119

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗