Contributing Factors in the Pathobiology of Airway Remodeling in Obesity
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ClinicalTrials.gov Identifier: NCT03115632 |
Recruitment Status :
Active, not recruiting
First Posted : April 14, 2017
Last Update Posted : December 16, 2022
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Condition or disease |
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Asthma Obesity Obesity, Morbid Bariatric Surgery Candidate |
Main Study
Specific Aim 1: Determine the effects of signaling on airway fibrosis and lung function in obese asthma and non-asthma patients. The investigators will:
•Perform assessments to determine if obese, early-onset asthma patients are more susceptible to airway fibrosis and remodeling than lean, early-onset asthma patients and obese and lean, non-asthma patients.◦
Specific Aim 2: Investigate the mechanism by which bariatric surgery slows the progression of airway fibrosis in obese human asthma. The investigators will:
•Perform assessments to determine if airway fibrosis in obese, early-onset asthma and obese non-asthma patients improves following bariatric surgery and weight loss◦
Study Type : | Observational |
Estimated Enrollment : | 43 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Contributing Factors in the Pathobiology of Airway Remodeling in Obesity |
Actual Study Start Date : | April 9, 2018 |
Estimated Primary Completion Date : | June 1, 2023 |
Estimated Study Completion Date : | June 1, 2023 |

Group/Cohort |
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Obese asthmatic & lean asthmatic
men and women with asthma and either obese or lean BMI
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Obese non-asthmatic & lean non-asthmatic
men and women without asthma and either obese or lean BMI
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Asthmatic undergoing bariatric surgery
Obese asthmatic men and women undergoing bariatric surgery
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Non-asthmatic undergoing bariatric surgery
Obese men and women undergoing bariatric surgery
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- Airway fibrosis [ Time Frame: Visit 2 (14 days) ]Obese asthmatics compared to lean asthmatics, obese non-asthmatics and lean non-asthmatics: A univariate linear model will be constructed to measure the effect of leptin or GLP-1 (glucagon-like peptide-1) on airway fibrosis, as measured by the ratio of Masson's trichrome-stained area to non-stained area in the sub-mucosal region of airway biopsy tissue.
- Change in airway fibrosis [ Time Frame: Visit 2 (14 days), Visit 4 (1 year + 14 days) ]Asthmatics undergoing bariatric surgery and non-asthmatics undergoing bariatric surgery: Each patient will serve as its own control in comparing pre- and post-operative airway fibrosis. A univariate linear model will be constructed to measure the effect of bariatric surgery on airway fibrosis, as measured by the ratio of Masson's trichrome-stained area to non-stained area in the sub-mucosal region of airway biopsy tissue.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Obese asthmatic & lean asthmatic
- 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 National Asthma Education and Prevention Program (NAEPP) guidelines.
- Lean subjects with body mass index (BMI) ≥ 20 kg/m2 and < 30 kg/m2 or obese subjects with BMI ≥ 30 and ≤ 55 kg/m2
- Physician diagnosis of asthma
- Forced expiratory volume at one second (FEV1) within acceptable limits (>45% predicted before and >55% predicted after, bronchodilator administration).
- Negative pregnancy test in women of childbearing potential (confirmed during screening).
- Relatively healthy subjects able to undergo bronchoscopy without complications.
- Willing and able to give informed consent and adhere to visit/protocol schedules.
- Read and write in English.
Obese non-asthmatic & Lean non-asthmatic
- Outpatient adults of either sex 18-60 years of age.
- Lean subjects with body mass index (BMI) ≥ 20 kg/m2 and < 30 kg/m2 or obese subjects with BMI ≥ 30 and ≤ 55 kg/m2
- Negative pregnancy test in women of childbearing potential (confirmed during screening).
- Normal lung function.
- No clinical history of atopy.
- No significant medical or psychological issues.
- Healthy subjects able to undergo bronchoscopy without complications.
- Willing and able to give informed consent and adhere to visit/protocol schedules.
- Read and write in English.
Asthmatic undergoing bariatric surgery
- 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.
- Physician diagnosis of asthma
- FEV1 within acceptable limits (>45% predicted before and >55% predicted after, bronchodilator administration).
- Morbidly obese subjects undergoing bariatric surgery and receiving care at the Duke Metabolic and Weight Loss Surgery Center.
- Negative pregnancy test in women of childbearing potential (confirmed during screening).
- Relatively healthy subjects able to undergo bronchoscopy without complications.
- Willing and able to give informed consent and adhere to visit/protocol schedules.
- Read and write in English.
Non-Asthmatic undergoing bariatric surgery
- Outpatient adults of either sex 18-60 years of age.
- Morbidly obese subjects undergoing bariatric surgery and receiving care at the Duke Metabolic and Weight Loss Surgery Center.
- Negative pregnancy test in women of childbearing potential (confirmed during screening).
- Normal lung function.
- No clinical history of atopy.
- No significant medical or psychological issues.
- Healthy subjects able to undergo bronchoscopy without complications.
- Willing and able to give informed consent and adhere to visit/protocol schedules.
- Read and write in English.
Exclusion Criteria:
- Children < 18 years of age.
- Adults ≥ 18 years of age with an initial asthma diagnosis at ≥ 12 years of age, as defined by the NHLBI NAEPP guidelines.
- Inpatient status.
- FEV1 is less than 45% predicted before, or less than 55% predicted after, bronchodilator administration.
- Upper or lower respiratory tract infection within one month of the study.
- Use of inhaled or systemic corticosteroids within four weeks of study.
- Use of long-acting beta-2, GLP-1 receptor agonists, or dipeptidyl peptidase-4 (DPP-4) inhibitors within two weeks of study.
- Smoking history > 5 pack years or any cigarette use within the previous six months.
- Significant non-asthma pulmonary disease (stable obstructive sleep apnea is not excluded).
- Positive pregnancy test for women and/or nursing women.
- An emergency department visit or inpatient admission for a primary respiratory diagnosis or treatment with antibiotics within 60 days of enrollment.
- Poorly controlled concomitant conditions that pose additional procedure risk as determined by the investigator.
- All patients on anticoagulants
- Uncontrolled sleep apnea
- Use of e-cigarettes or "vape" devices of any kind

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115632
United States, North Carolina | |
Duke Metabolic and Weight Loss Surgery Center | |
Durham, North Carolina, United States, 27704 | |
Duke Asthma Allergy and Airway Center | |
Durham, North Carolina, United States, 27705 |
Principal Investigator: | Loretta Que, MD | Duke University |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT03115632 |
Other Study ID Numbers: |
Pro00077482 |
First Posted: | April 14, 2017 Key Record Dates |
Last Update Posted: | December 16, 2022 |
Last Verified: | December 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Obesity Obesity, Morbid Airway Remodeling Overnutrition |
Nutrition Disorders Overweight Body Weight Pathological Conditions, Anatomical |