Mechanisms and Mediators of Lung Disease

HIC Number:
0102012268

Full Title:
Mechanisms and Mediators of Lung Disease

Principal Investigator(s):

Summary/Objective:
The purpose of this study is to investigate the development and natural history of lung diseases and identify genes, molecules and pathways that are associated with disease development, progression and severity. 

Description
Eligibility
 
Gender:
Both 

Minimum Age:
18 Years 

Age Range:
18 Years and older 

Criteria:
INCLUSION/EXCLUSION for Essential Testing:
Two groups of subjects will be recruited for participation into the study 1) normal subjects without lung disease (including family members); 2) subjects with lung disease.  The inclusion criteria for subjects with lung disease is  1) age > 12 years of age. The inclusion criteria for subjects without lung disease is 1) age > 18 years of age.  Exclusion criteria include: 1) known history of HIV or hepatitis C; 2) a severe medical condition such as unstable angina or uncontrolled diabetes; or 3) any patient with a history of a severe reaction to any of the study procedures.  All eligible subjects (as deemed appropriate according to their disease status and age as noted above) will be invited to complete the essential testing portion of the study as detailed earlier in the protocol.  Inclusion/exclusion criteria apply to all levels of testing including baseline, follow-up and exacerbation testing including patients on mechanical ventilation.  All the procedures including blood draw, exhaled breath condensate and pulmonary function tests carry minimal risk, but any subject with a history of significant reaction to any of the procedures will be excluded from that portion of the study.
 
All subjects with a contraindication to any of the essential testing will be excluded. These exclusions include subjects (adults and adolescents) with severe cardiovascular, renal, or liver disease, bleeding diathesis, or advanced neuromuscular disease.
 
INCLUSION/EXCLUSION for Supplemental Testing (Not to be done with adolescents greater than or equal to 12 years of age):
Study investigators will invite some of the subjects participating in the essential testing portion of the study to undergo supplemental testing. (This may include subjects undergoing bronchoscopy as part of their normal care.  The only additional exclusion criteria for this testing that is different from the essential testing inclusion/exclusion criteria is pregnancy.  Subjects who report (all subjects will be questioned on the day of testing) being pregnant or report a risk of pregnancy,  will have supplemental testing delayed until it is determined they are not pregnant.  Additional specific exclusion criteria for each of these tests is listed below:
 
HRCT:
None

Methacholine challenge:
Recent (within 30 days) exacerbation of asthma/COPD

Sputum induction( affected adolescents will participate in this):
Recent (within 30 days) exacerbation of asthma/COPD

Bronchoscopy:
COPD, FEV1 <30%,³ 2Liters O2 by nasal canula
History of a bleeding disorder or on anticoagulants