Observational StudyMechanistic Insights From Bronchoscopy Airway Samples

Inclusion Criteria:

• Healthy Controls

1. Male and female subjects between the ages of 18 and 70 years
2. Ability to provide written informed consent and ability to comply with the requirements of the study
3. No hyperreactivity to methacholine (PC20 FEV1 Methacholine >16 mg/mL)
4. No history of allergic rhinitis/seasonal allergies

• Asthmatics

1. Male and female subjects between the ages of 18 and 70 years
2. Ability to provide written informed consent and ability to comply with the requirements of the study
3. History of asthma
4. No use of oral or inhaled corticosteroids for the treatment of asthma during the past 6 weeks
5. Hyperreactivity to methacholine (PC20 FEV1 Methacholine < 8 mg/ml)

Exclusion Criteria:

The same exclusion criteria will apply to both Sub-studies.

1. Current smokers, defined by (a) >5 cigarettes smoked in past 12 months, and (b) ≤ 8 weeks since last time smoking; or former smokers who have a total smoking history

• 10 pack-years

2. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
3. Subjects with a history of lung disease other than asthma
4. Subjects with a history of prior esophageal hernia surgery
5. Subjects with a history of a medical disease, which in the opinion of the Investigator may put the subject at extra risk from study-related procedures or because the disease may influence the results of the study
6. Current participation in an investigational drug trial

Prohibited Medications and Treatments The following medications are prohibited during the study and must be discontinued prior to enrollment for the amount of time specified below.

1. Astemizole: 12 weeks
2. Steroids (oral, inhaled or nasal): 6 weeks
3. Nedocromil sodium, sodium cromoglycate: 4 weeks
4. Long-acting methylxantines: 2 days
5. Short-acting methylxantines: 12 hours
6. Montelukast: 7 days
7. Zafirlukast: 7 days
8. Salmeterol: 2 days
9. Omalizumab: 6 months

Medications to be withheld prior to bronchoscopy: Aspirin or Non- steroidal anti-inflammatory agents (NSAIDs) for 2 days Medications to be withheld before each clinic visit: Short-acting bronchodilators (e.g. Albuterol) for 6 hours; Short-acting anti- cholinergics (e.g. Atrovent, Combivent) for 8 hours; and antihistamines (e.g. Benadryl, Claritin) for 3 days.