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Clinical Trial

Effectiveness of DITM Versus IMT in COPD Patients

NCT: NCT06958666 · RECRUITING

NCT IDNCT06958666
StatusRECRUITING
Start Date2025-06-30
Completion2028-05
SponsorSir Run Run Shaw Hospital (OTHER)
First posted
Last updated

Brief 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 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.

Frequently Asked Questions

What is Effectiveness of DITM Versus IMT in COPD Patients?

Effectiveness of DITM Versus IMT in COPD Patients is a clinical trial registered under NCT06958666. Current status: RECRUITING.

What is the status of NCT06958666?

The current status of NCT06958666 (Effectiveness of DITM Versus IMT in COPD Patients) is: RECRUITING.

When did Effectiveness of DITM Versus IMT in COPD Patients start?

Effectiveness of DITM Versus IMT in COPD Patients started on 2025-06-30.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.