Search / Trial NCT00001462

Characterization of the Pathobiology of Early Lung Destruction in Alpha 1-Antitrypsin Deficient Individuals

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Dec 9, 2002

Apply for Trial

Trial Information

Current as of December 10, 2023

Completed

Keywords

Alpha 1 Antitrypsin Deficiency Emphysema Genetic Diseases Inflammation Nitric Oxide Protease

Description

Alpha 1-antitrypsin-deficient individuals develop severe destructive lung disease much earlier and their lung function declines faster than the general population of individuals with chronic obstructive lung disease. This study is designed to better understand the pathogenesis of lung destruction in alpha 1-antitrypsin deficient individuals and to characterize the pathobiology of early lung destruction. To accomplish this we intend to use bronchoalveolar lavage to determine and quantify the factors that initiate and sustain lung inflammation in alpha 1-antitrypsin deficient individuals with...

Gender

All

Eligibility criteria

  • Any alpha 1 antitrypsin-deficient individuals.
  • 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.

Attachments

readout_NCT00001462_2023-12-10.pdf

4.5 MB

NCT00001462_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Discussion 0