Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
NCT ID:
NCT06958666
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT06958666
Study Brief:
Protocol Section:
NCT06958666