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 @ 5:20 PM
Ignite Modification Date:
2025-12-24 @ 5:20 PM
NCT ID:
NCT06410950
Eligibility Criteria:
Inclusion criteria for the COPD group:
Diagnosis of COPD: Confirmed diagnosis of COPD based on GOLD spirometry criteria:
Post-bronchodilator FEV1/FVC ratio \< 0.70 Documented history of respiratory symptoms (e.g., dyspnea, cough, sputum production) Stable COPD: No COPD exacerbations requiring hospitalization in the past 6 months.
Smoking History: Current or former smoker with a documented smoking history of at least 10 pack-years (cumulative cigarette consumption).
Age: 45-75 years old. Ability to Understand and Follow Instructions: Mentally competent and able to understand the study procedures, risks, and benefits, providing written informed consent.
Exclusion criteria for the COPD group:
Other respiratory disease than COPD. Severe COPD exacerbation: anyone with a COPD exacerbation requiring hospitalization within the last six months.
Conditions limiting chest wall movement: severe kyphosis, ankylosing spondylitis, or similar conditions that significantly impact the ability to expand the chest wall and perform respiratory muscle assessments.
Muscular or neuromuscular disorders: primary muscular diseases (e.g., muscular dystrophy) or neuromuscular disorders affecting muscle function (e.g., Parkinson's, multiple sclerosis).
Recent Surgery or Trauma: Significant surgery or trauma within the past three months that might affect muscle function or the ability to perform assessments.
Uncontrolled comorbidities: severe, uncontrolled medical conditions that could significantly impact muscle function or confound the study results (e.g., uncontrolled heart failure, advanced renal disease).
Inclusion criteria for the healthy control group:
No History of Respiratory Disease: free from any current or past respiratory diagnoses, including asthma, chronic bronchitis, or recurrent respiratory infections.
Normal lung function: spirometry testing will confirm normal lung function with a post-bronchodilator FEV1/FVC ratio \> 0.70 and no evidence of airflow obstruction.
No significant chronic conditions: free from any major chronic medical conditions that could impact muscle function or confound the results (e.g., uncontrolled diabetes, heart failure, advanced liver disease).
Age: 45-75 years old Ability to understand and follow instructions: mentally competent and able to understand the study procedures, risks, and benefits, providing written informed consent.
No recent infections: free from any recent respiratory or other infections within the past 4 weeks.
Non-smoker or minimal smoking history: non-smokers or have a very minimal smoking history (less than 10 pack-years)
Exclusion criteria for the healthy control group:
Recent respiratory infection: anyone with a current respiratory tract infection (viral or bacterial) within the past four weeks.
Mild respiratory symptoms: Even mild, persistent respiratory symptoms (chronic cough, sputum production) within the past 4 weeks.
Conditions limiting chest wall movement: severe kyphosis, ankylosing spondylitis, or similar conditions that significantly impact the ability to expand the chest wall and perform respiratory muscle assessments.
Muscular or neuromuscular disorders: primary muscular diseases (e.g., muscular dystrophy) or neuromuscular disorders affecting muscle function (e.g., Parkinson's, multiple sclerosis).
Recent Surgery or Trauma: Significant surgery or trauma within the past three months that might affect muscle function or the ability to perform assessments.
Uncontrolled comorbidities: severe, uncontrolled medical conditions that could significantly impact muscle function or confound the study results (e.g., uncontrolled heart failure, advanced renal disease).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT06410950
Study Brief:
Protocol Section:
NCT06410950