The Use of High Resolution Chest Computed Tomography in Alpha-1 Antitrypsin Deficiency

Completed

Conditions studied: Alpha-1 Antitrypsin Deficiency

In brief

Individuals with a deficiency of alpha-1 antitrypsin (AAT) often develop emphysema. Traditional lung function tests may not be the most accurate way to measure the progression of emphysema. This study will compare high resolution computed tomography (CT) scans to spirometry to measure the progression of emphysema.

Key facts

Study ID

NCT00532805

Run by

Medical University of South Carolina

People needed

49

Starts

2007-08-01

Expected to finish

2012-04-01

Last updated by the study team

2018-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of AAT deficiency, as determined by both of the following conditions:
• Serum A1-P1 levels less than 11uM or 80 mg/dL
• 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

You may not qualify if…

• 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

Where it is running

• National Jewish Medical and Research Center — Denver, Colorado, United States
• University of Florida Medical Center — Gainesville, Florida, United States
• Harvard/Brigham and Women's Hospital — Boston, Massachusetts, United States
• Cincinnati Children's Medical Center — Cincinnati, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Oregon Health and Sciences University — Portland, Oregon, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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