AsthmaNCT03115632
Contributing Factors in the Pathobiology of Airway Remodeling in Obesity
An observational study of Asthma and Obesity, run by Duke University at 2 sites in United States.
Trial summary
There are two aims for this study. The purpose of this study is to determine the effects of body weight and hormones on airway fibrosis (scarring) and lung function in obese \& lean asthma subjects compared to obese \& lean non-asthma subjects (Aim 1). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Obesity, Obesity, Morbid
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Apr 2018to 27 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects will be recruited from the clinics of the Duke Asthma, Allergy and Airway Center, the Duke Metabolic and Weight Loss Surgery Center, the Duke Raleigh Weight Loss Surgery Center, and the Duke Diet and Fitness Center. Healthy controls without lung disease will be recruited from the surrounding area.
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke Metabolic and Weight Loss Surgery Center
Durham, North Carolina, 27704
Duke Asthma Allergy and Airway Center
Durham, North Carolina, 27705
About this study
There are two aims for this study. The purpose of this study is to determine the effects of body weight and hormones on airway fibrosis (scarring) and lung function in obese \& lean asthma subjects compared to obese \& lean non-asthma subjects (Aim 1). And in obese subjects with asthma undergoing bariatric surgery compared to obese non-asthma subjects undergoing bariatric surgery (Aim 2).
Read the detailed description
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◦
- Conditions
- Asthma, Obesity, Obesity, Morbid, Bariatric Surgery Candidate
- Medical subject headings
- Asthma, Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obese asthmatic & lean asthmatic | men and women with asthma and either obese or lean BMI | |
| Obese non-asthmatic & lean non-asthmatic | men and women without asthma and either obese or lean BMI | |
| Asthmatic undergoing bariatric surgery | Obese asthmatic men and women undergoing bariatric surgery | |
| Non-asthmatic undergoing bariatric surgery | Obese men and women undergoing bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway fibrosis
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.
Measured: Visit 2 (14 days)
Change in airway fibrosis
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.
Measured: Visit 2 (14 days), Visit 4 (1 year + 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start9 Apr 2018
- Primary completion27 Jun 2023
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loretta Que, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115632
- Sponsor's protocol ID
- Pro00077482
- Status last verified
- Jun 2023
- First submitted
- 4 Apr 2017
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contributing Factors in the Pathobiology of Airway Remodeling in Obesity
- ClinicalTrials.gov ID
- NCT03115632
- Acronym / sponsor ID
- Pro00077482
- Conditions
- Asthma, Obesity, Obesity, Morbid, Bariatric Surgery Candidate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are two aims for this study. The purpose of this study is to determine the effects of body weight and hormones on airway fibrosis (scarring) and lung function in obese \& lean asthma subjects compared to obese \& lean non-asthma subjects (Aim 1). And in obese subjects with asthma undergoing bariatric surgery compared to obese non-asthma subjects undergoing bariatric surgery (Aim 2).
Detailed description
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Obese asthmatic & lean asthmatic | – | –men and women with asthma and either obese or lean BMI |
| Obese non-asthmatic & lean non-asthmatic | – | –men and women without asthma and either obese or lean BMI |
| Asthmatic undergoing bariatric surgery | – | –Obese asthmatic men and women undergoing bariatric surgery |
| Non-asthmatic undergoing bariatric surgery | – | –Obese men and women undergoing bariatric surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects will be recruited from the clinics of the Duke Asthma, Allergy and Airway Center, the Duke Metabolic and Weight Loss Surgery Center, the Duke Raleigh Weight Loss Surgery Center, and the Duke Diet and Fitness Center. Healthy controls without lung disease will be recruited from the surrounding area.
Key inclusion criteria (38 listed)
- 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).
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loretta Que, MD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Obesity, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 38 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Airway fibrosis (time frame: Visit 2 (14 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.