Effectiveness of DITM Versus IMT in COPD Patients

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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
• Устройство 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.

Первичные конечные точки

• Rate of acute exacerbation of moderate-to-severe COPD and hospitalization during follow-up period [Срок оценки: Follow-up assessments are collected 3 months, 6 months, and 12 months after their initial training]

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 9 центров

• Zhejiang Provincial Hospital of Traditional Chinese Medicine — Ханчжоу
• Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Ханчжоу
• 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
• … и ещё 1 центр

Публикации

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• 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

Идентификаторы

NCT: NCT06958666 · 20250119

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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