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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT01682018
Eligibility Criteria:
Inclusion Criteria:
Single lung transplantation due to emphysema at least six months following transplantation that developed native lung overinflation
* Age from 40 to 75 years
* BMI \< 32 kg/m2
* FEV1 \< 40% of predicted value, FEV1/FVC \< 70%
* TLC \> 120% predicted, RV \> 150% predicted.
* Stable with \< 20 mg prednisone (or equivalent) qd
* PaCO2 \< 50mm Hg
* PaO2 \> 45 mm Hg on room air
* 6-min walk of \> 50m (without rehabilitation) or \> 100m (with rehabilitation)
* Nonsmoking for 4 months prior to initial interview and throughout screening
* The patient agrees to all protocol required follow-up intervals.
* The patient has no child bearing potential
* The patient is willing and able to complete protocol required baseline assessments and procedures Exclusion criteria
* Prior endobronchial treatment for emphysema
* Pleural or interstitial disease that precludes surgery.
* Prior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy.
* Clinically significant bronchiectasis
* Pulmonary nodule requiring surgery
* History of recurrent respiratory infections (\> 3 hospitalization in the last year)
* Clinically significant (\> 4 Tablespoons per day) sputum production
* Fever, elevated white cell count, or other evidence of active infection
* Dysrhythmia that might pose a risk during exercise or training
* Congestive heart failure within 6 mo and LVEF \< 45%
* Evidence or history of Cor Pulmonale
* Resting bradycardia (\< 50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT
* History of exercise-related syncope
* MI within 6 mo and LVEF \< 45%
* Evidence of systemic disease or neoplasia expected to compromise survival during 5-yr period
* Any disease or condition that interferes with completion of initial or follow-up assessments
* Patient is currently enrolled in another clinical trial
* Patient is unable to complete 3 minutes of unloaded peddling on cycle ergometer
* Alpha-1-Antitrypsin Deficiency
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01682018
Study Brief:
Protocol Section:
NCT01682018