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Compares treatment options for COPD (Chronic Obstructive Pulmonary Disease)
Official title Effectiveness of DITM Versus IMT in COPD Patients
ClinicalTrials.gov ID: NCT06958666
What this study is testing
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- 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...
- Uses Budesonide MDI (Breztri Aerosphere) or Fluticasone, umeclidinium, and vilanterol (Trelegy Ellipta) or umeclidinium and vilanterol (Anoro...
- 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...
You likely can't join if
- 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
See the full eligibility 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.