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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT00205920
Eligibility Criteria:
Inclusion Criteria include:
* Clinical diagnosis of advanced emphysema
* Age \> 18 years at the time of initial presentation
* Clinically significant dyspnea (MRC Dyspnea \>/= 2)
* Laboratory tests within protocol-specified ranges
* Pulmonary function tests
Exclusion Criteria include:
* Alpha-1 protease inhibitor deficiency verified by a serum level of \<80mg% or knowledge of PI\*ZZ genotype
* Tobacco use within 16 weeks of the initial clinic visit
* Body mass index \< 15 kg/m2 or \> 35 kg/m2
* Clinically significant asthma (reversible airway obstruction), chronic bronchitis or bronchiectasis
* Allergy to fish or pork products or sensitivity to tetracycline
* FEV1 \<20% predicted with DLCO \<20% predicted or homogeneous disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00205920
Study Brief:
Protocol Section:
NCT00205920