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:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT01869205
Eligibility Criteria:
Inclusion Criteria:
* Age more than 40 and below 75
* Patients with smoking history and heterogenous emphysema on chest CT
* Advanced emphysema (FEV1/FVC \<70%, FEV1 of 15-45%, TLC \>100% and RV \>150% predicted)
* Persistent symptoms refractory to treatment
* PaCO2 \<50 mmHg and PaO2 \>45 mmHg
* Body mass index (BMI) ≤31.1 kg/m2 (men) or ≤32.3 kg/m2 (women)
* 6-min walk distance \>140 m after pulmonary rehabilitation
Exclusion Criteria:
* Diffusing capacity (DLco) \<20% predicted
* Large bullae (exceed 5 cm)
* Alpha-1 antitrypsin deficiency
* History of thoracotomy
* Excessive sputum production (throughout the week)
* Severe pulmonary hypertension ( systolic pulmonary artery pressure ≥ 45mmHg, estimated from the peak velocity of a tricuspid regurgitant jet by doppler echocardiography)
* Acute respiratory infection
* Unstable angina, congestive heart failure, or acute myocardial infarction in 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT01869205
Study Brief:
Protocol Section:
NCT01869205