Sample Collections From the Airways of Asthmatic Patients

• 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 either an abnormal methacholine challenge or evidence of ongoing reversible airway obstruction. An abnormal methacholine challenge will be defined as a decrease in FEV(1) of at least 20% following inhalation of less than or equal to 4 mg/ml of methacholine. Ongoing 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.

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

EXCLUSION CRITERIA:

ASTHMATICS:

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

Respiratory tract infection or asthma exacerbation within 4 weeks of screening.

History of adverse reactions to lidocaine or other local anesthetics.

Allergy to methacholine.

Use of aspirin within 2 weeks of the bronchoscopic study or non-steroidal anti-inflammatory agents within 2 days of the bronchoscopic study.

History of cigarette smoking or electronic cigarette smoking within the past 3 months.

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).

Post-bronchodilator FEV1 < 40% of predicted or pre-bronchodilator FEV1 < 35% of predicted. .

Active bronchospasm on physical examination.

History of lidocaine allergy.

History of prior cardiac disease.

For Bronchial Biopsies: PT and PTT greater than ULN.

For Bronchial Brushings or BAL:

• PT greater than 1 second above ULN or INR greater than 1.3.
• PTT greater than 1 second above ULN.

Platelet less than 150,00/ml.

Hemoglobin less than 12 gm/dl for males and less than 11 gm/dl for females.

Serum Creatine greater than 2.0.

Liver function tests greater than 2 times upper limit of normal.

Any condition that, in the investigator's opinion, places the patient at undue risk for complications from fiberoptic bronchoscopy, bronchalveolar lavage, bronchial brushings, or bronchial biopsies.

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, following inhalation of 16 mg/ml of methacholine.

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.

EXCLUSION CRITERIA - RESEARCH VOLUNTEERS:

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