Contributing Factors in the Pathobiology of Airway Remodeling in Obesity

Inclusion Criteria:

Obese asthmatic & lean asthmatic

1. Outpatient adults of either sex 18-60 years of age with an initial asthma diagnosis at
< 12 years of age, as defined by the NHLBI NAEPP guidelines.

2. Lean subjects with body mass index (BMI) ≥ 20 kg/m2 and < 30 kg/m2 or obese subjects
with BMI ≥ 30 and ≤ 50 kg/m2

3. Physician diagnosis of asthma

4. FEV1 within acceptable limits (>45% predicted before and >55% predicted after,
bronchodilator administration).

5. Negative pregnancy test in women of childbearing potential (confirmed during
screening).

6. Relatively healthy subjects able to undergo bronchoscopy without complications.

7. Willing and able to give informed consent and adhere to visit/protocol schedules.

8. Read and write in English.

Obese non-asthmatic & Lean non-asthmatic

1. Outpatient adults of either sex 18-60 years of age.

2. Lean subjects with body mass index (BMI) ≥ 20 kg/m2 and < 30 kg/m2 or obese subjects
with BMI ≥ 30 and ≤ 50 kg/m2

3. Negative pregnancy test in women of childbearing potential (confirmed during
screening).

4. Normal lung function.

5. No clinical history of atopy.

6. No significant medical or psychological issues.

7. Healthy subjects able to undergo bronchoscopy without complications.

8. Willing and able to give informed consent and adhere to visit/protocol schedules.

9. Read and write in English.

Asthmatic undergoing bariatric surgery

1. Outpatient adults of either sex 18-60 years of age with an initial asthma diagnosis at
< 12 years of age, as defined by the NHLBI NAEPP guidelines.

2. Physician diagnosis of asthma

3. FEV1 within acceptable limits (>45% predicted before and >55% predicted after,
bronchodilator administration).

4. Morbidly obese subjects undergoing gastric bypass or sleeve gastrectomy and receiving
care at the Duke Metabolic and Weight Loss Surgery Center.

5. Negative pregnancy test in women of childbearing potential (confirmed during
screening).

6. Relatively healthy subjects able to undergo bronchoscopy without complications.

7. Willing and able to give informed consent and adhere to visit/protocol schedules.

8. Read and write in English.

Non-Asthmatic undergoing bariatric surgery

1. Outpatient adults of either sex 18-60 years of age.

2. Morbidly obese subjects undergoing gastric bypass or sleeve gastrectomy and receiving
care at the Duke Metabolic and Weight Loss Surgery Center.

3. Negative pregnancy test in women of childbearing potential (confirmed during
screening).

4. Normal lung function.

5. No clinical history of atopy.

6. No significant medical or psychological issues.

7. Healthy subjects able to undergo bronchoscopy without complications.

8. Willing and able to give informed consent and adhere to visit/protocol schedules.

9. Read and write in English.

Exclusion Criteria:

1. Children < 18 years of age.

2. Adults ≥ 18 years of age with an initial asthma diagnosis at ≥ 12 years of age, as
defined by the NHLBI NAEPP guidelines.

3. Inpatient status.

4. FEV1 is less than 45% predicted before, or less than 55% predicted after,
bronchodilator administration.

5. Upper or lower respiratory tract infection within one month of the study.

6. Use of inhaled or systemic corticosteroids within four weeks of study.

7. Use of long-acting beta-2, GLP-1R agonists, or dipeptidyl peptidase-4 (DPP-4)
inhibitors within two weeks of study.

8. Smoking history > 5 pack years or any cigarette use within the previous six months.

9. Significant non-asthma pulmonary disease (stable obstructive sleep apnea is not
excluded).

10. Positive pregnancy test for women and/or nursing women.

11. An ED visit or inpatient admission for a primary respiratory diagnosis or treatment
with antibiotics within 60 days of enrollment.

12. Poorly controlled concomitant conditions that pose additional procedure risk as
determined by the investigator.

13. Uncontrolled sleep apnea