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

Trial Information

Current as of December 26, 2024

Completed

Keywords

Alpha 1 Antitrypsin Deficiency Emphysema Genetic Diseases Inflammation Nitric Oxide Protease

ClinConnect Summary

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.

About National Heart, Lung, And Blood Institute (Nhlbi)

The National Heart, Lung, and Blood Institute (NHLBI) is a leading component of the National Institutes of Health (NIH), dedicated to advancing research and clinical trials focused on cardiovascular, pulmonary, and hematologic diseases. With a mission to improve public health through innovative research, the NHLBI supports a wide range of studies aimed at understanding, preventing, and treating heart and lung conditions. By collaborating with academic institutions, healthcare providers, and patient communities, the NHLBI strives to translate scientific discoveries into effective clinical practices, ultimately enhancing the quality of life for individuals affected by these critical health issues.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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