Characterization of the Pathobiology of Early Lung Destruction in Alpha 1-Antitrypsin Deficient Individuals
NCT ID: NCT00001462
Last Updated: 2008-03-04
Study Results
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Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
1995-05-31
2000-04-30
Brief Summary
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Detailed Description
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Conditions
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Eligibility Criteria
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Inclusion Criteria
18-65 years old.
FEV1 greater than 1 equal to 50 percent of predicted (forced expiratory volume).
Study participation is required for one year.
A total of four bronchoscopies will be performed over a year period.
Methacholine challenge test will be performed at the beginning and end of the study to assess the degree of reactive airways disease.
Pneumococcal and annual influenza vaccine will be given.
No prolastin within one year prior to start of the study.
No oral systemic corticosteroids within 30 days prior to start of study.
No allergy to topical or local anesthetic (i.e., lidocaine).
No pregnancy.
No HIV positive patients.
No Hepatitis B/C virus positive patients.
No patients with any condition associated with immunodeficiency.
No patients with presence of significant cardiac diseases.
No patients with presence of uncorrected blood-clotting disorders.
No patients with any oxygen at home on a regular basis.
No adverse reactions to methacholine.
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Locations
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National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, United States
Countries
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References
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Buist AS. Alpha 1-antitrypsin deficiency in lung and liver disease. Hosp Pract (Off Ed). 1989 May 15;24(5):51-9. doi: 10.1080/21548331.1989.11703712. No abstract available.
Crystal RG. Alpha 1-antitrypsin deficiency, emphysema, and liver disease. Genetic basis and strategies for therapy. J Clin Invest. 1990 May;85(5):1343-52. doi: 10.1172/JCI114578. No abstract available.
Gadek JE, Pacht ER. The protease-antiprotease balance within the human lung: implications for the pathogenesis of emphysema. Lung. 1990;168 Suppl:552-64. doi: 10.1007/BF02718178.
Paris AE, Vragovic O, Sonalkar S, Finneseth M, Borgatta L. Mifepristone and misoprostol compared to osmotic dilators for cervical preparation prior to surgical abortion at 15-18 weeks' gestation: a randomised controlled non-inferiority trial. BMJ Sex Reprod Health. 2019 Nov 21:bmjsrh-2019-200367. doi: 10.1136/bmjsrh-2019-200367. Online ahead of print.
Other Identifiers
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95-H-0116
Identifier Type: -
Identifier Source: secondary_id
950116
Identifier Type: -
Identifier Source: org_study_id
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