Sample Collections From the Airways of Asthmatic Patients

This tissue procurement protocol proposes to perform bronchoscopy with bronchoalveolar
lavage, bronchial brushings, and bronchial wall biopsies as well as to collect samples of
sputum, exhaled breath condensates and blood, in order to evaluate the molecular mechanisms
underlying the pathogenesis of airway inflammation, airway hyperresponsiveness, and airway
remodeling in asthmatic subjects.

- INCLUSION CRITERIA:

ASTHMATICS:

Patients will be between 18 and 75 years of age, male or female.

The diagnosis of asthma requires a history of intermittent, reversible expiratory flow
limitation.

In addition, patients will have demonstrated evidence of either an abnormal methacholine
challenge or reversible airway obstruction. An abnormal methacholine challenge will be
defined as a decrease in FEV(1) of at least 20% at a PD(20) dose less than 240 micrograms.
Reversible airway obstruction will be defined as an improvement of at least 12% and 200 cc
in either the FEV(1) or FVC folowing bronchodilator treatment. Methacholine challenge
testing will not be performed if the subject has a history of allergy to methoacholine.
Result of testing performed by the subject's primary care provider may be accepted as
evidence of reversible airflow obstruction.

For women of childbearing potential, negative pregnancy test prior to study and willingness
to adhere to reliable birth control methods during the study.

Asthmatic research subjects who will only be providing research blood specimens and will
not be undergoing a research bronchoscopy may participate in the protocol by providing a
clinical history that they have asthma and are not pregnant. Documentation of an abnormal
methacholine challenge or reversible airflow obstruction or a negative pregnancy test, for
women of childbearing age, will not be required for donation of research blood specimens.

EXCLUSION CRITERIA:

ASTHMATICS:

Diagnosis of a pulmonary disorder other than asthma (e.g., chronic bronchitis, cystic
fibrosis, HIV-related lymphocytic airway inflammation).

History of drug or alcohol abuse within the past year.

Positive test for human immunodeficiency virus (to exclude patients with HIV-related
lymphocytic airway inflammation).

INCLUSION CRITERIA - RESEARCH VOLUNTEERS:

Research volunteers will be between 18 and 75 years of age, male or female.

A negative inhalational methacholine challenge as defined bv the absence of a 20% decrease
in FEV(1), at a PD(20) dose of >960 micrograms (normal bronchial hyperresponsiveness).
Methacholine challenge testing will not be performed if the subject has a history of
allergy to methacholine. Results of testing performed by the subject's primary care
provider may be accepted as evidence of a negative methacholine challenge.

For women of childbearing potential, negative pregnancy test within 2 weeks prior to study
and willingness to adhere to reliable birth control methods during the study.

Research volunteers who will only providing research blood specimens and will not be
undergoing a research bronchoscopy may be included in the protocol without documentation of
a negative inhalational methacholine challenge or a negative pregnancy test if they provide
a history that they do not have asthma and that they are not currently pregnant, for women
of childbearing age.

EXCLUSION CRITERIA - RESEARCH VOLUNTEERS:

Same as the asthmatic exclusion criteria plus a history of asthma.