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 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT00532805
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of AAT deficiency, as determined by both of the following conditions:
1. Serum A1-P1 levels less than 11uM or 80 mg/dL
2. Protease inhibitor phenotype Z (PiZZ) or Znull phenotype confirmed by gene probe analysis. Previous serum levels and phenotype results are acceptable if documented from a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.
* FEV1 greater than or equal to 80% of the predicted value
Exclusion Criteria:
* Pregnant or intending to become pregnant within 4 years of study entry
* Previous lung transplantation
* Sibling of a participant who is already enrolled in the study
* Unable to attend scheduled clinic visits
* Currently smokes cigarettes or marijuana or quit smoking cigarettes or marijuana in the 1 year prior to study entry
* Current or planned use of oral tobacco products or nicotine replacement products
* Evidence of significant long-term or acute inflammation outside the lung, including connective diseases, panniculitis, or acute infection
* Unwilling to alter bronchodilator medications for 24 hours prior to scheduled quantitative CT (QCT) scans
* Musculoskeletal disease that limits exercise by walking
* Required to take any of the following medications within 48 hours of scheduled lung function testing: dicyclomine (Bentyl), propantheline (Pro-Banthine), mepenzolate (Cantil), methscopolamine (Pamine), and scopolamine (Transderm-Scop)
* Known allergy or intolerance to tiotropium or albuterol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00532805
Study Brief:
Protocol Section:
NCT00532805