AsthmaIMAPNCT05757583
Impact of Metabolic Dysfunction and Mucus Plugging on Asthma Physiology
An observational study of Asthma, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a single-center study of 80 subjects with asthma including those with obesity and metabolic dysfunction (MD), those with obesity and without metabolic dysfunction, those with severe asthma and mucus plugging and those with severe asthma and without mucus plugging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2023to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will recruit up to 80 asthma participants, at least 20 with obesity and MD, 20 with obesity and no MD, 20 with severe asthma and mucus plugs and 20 with severe asthma and no mucus plugs.
Who may be able to join
- Male or female ≥ 18 years old at Visit 0
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- History of physician diagnosed asthma
- Evidence of bronchodilator reversibility (12% improvement in FEV1 after albuterol administration) or positive methacholine challenge PC20 or PD20. Historical evidence is accepted.
- Meets criteria for obesity or severe asthma a. Obesity: BMI≥30 i. Metabolic dysfunction is defined as presence of either:
- 1. IL-6 high: Plasma IL-6 > 3.0 pg/mL 2. Insulin resistance: HOMA-IR > 3 mass units b. Severe asthma: Requires treatment with high dose inhaled corticosteroids plus a second controller, systemic corticosteroid, or biologic therapy.
- Mucus Plugging is defined as mucus plug score ≥ 4
Who cannot join
- Asthma exacerbation or URI within the previous 6 weeks.
- History of smoking
- If <30 years old: Smoked for ≥5 pack-years
- If ≥30: Smoked for ≥10 pack years
- Pregnancy
- Absolute or relative contraindication to exercise testing per ATS criteria
- Any other criteria that place the subject at unnecessary risk according to the judgment of the Principal Investigator and/or attending physician of record.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Airway Clinical Research Center
San Francisco, California, 94143
About this study
This is a single-center study of 80 subjects with asthma including those with obesity and metabolic dysfunction (MD), those with obesity and without metabolic dysfunction, those with severe asthma and mucus plugging and those with severe asthma and without mucus plugging. Screening data will be reviewed to determine participant eligibility. Participants who meet all inclusion criteria will participate in a cardiopulmonary exercise testing (CPET) visit to compare lung function markers and change in oxygen saturation between obese patients with and without MD and severe asthma patients with and without mucus plugging.
Read the detailed description
The mechanism of poor exercise tolerance in patients with severe asthma is poorly understood. In preliminary data, the investigators have identified increases in air trapping in patients with obese asthma and metabolic dysfunction and patients with asthma and mucus plugs. The investigators have also found air trapping on CT (Computerized Tomography) scans of severe asthma patients with mucus plugs. Therefore, the investigators hypothesize that obese patients with metabolic dysfunction (MD) and severe asthma patients with mucus plugs develop changes in lung function during exercise.
To test this hypothesis, this protocol will plan for cardiopulmonary exercise testing in patients with obesity or severe asthma. The analyses will compare dynamic hyperinflation, expiratory flow limitation, and the RV/TLC ratio (ratio of residual volume to total lung capacity) before and after exercise between obese patients with and without MD and severe asthma patients with and without mucus plugs.
- Conditions
- Asthma
- Medical subject headings
- Asthma
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 |
|---|---|---|
| Patients with asthma, obesity and metabolic dysfunction | Otherwise healthy asthmatic subjects with: 1. Body Mass Index (BMI) ≥ 30; and 2. Metabolic dysfunction evidenced by at least one of the following: * high plasma IL-6 (> 3.0 pg/mL) * insulin resistance (HOMA-IR > 3 mass units) | |
| Patients with asthma, obesity and no metabolic dysfunction | Otherwise healthy asthmatic subjects with: 1. Body Mass Index (BMI) ≥ 30; and 2. No evidence of metabolic dysfunction | |
| Patients with severe asthma and mucus plugs | Otherwise healthy asthmatic subjects: 1. Requiring treatment with high dose inhaled corticosteroids plus a second controller, systemic corticosteroid, or biologic therapy; and 2. Evidence of mucus plugs as defined by a mucus plug score ≥ 4 | |
| Patients with severe asthma and no mucus plugs | Otherwise healthy asthmatic subjects: 1. Requiring treatment with high dose inhaled corticosteroids plus a second controller, systemic corticosteroid, or biologic therapy; and 2. No evidence of mucus plugs as defined by a mucus plug score < 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EELV (End Expiratory Lung Volume)
We will compare change in EELV during the CPET (Cardiopulmonary Exercise Test) between the obese asthma patients with MD or without MD and between the patients with severe asthma with mucus plugs or without mucus plugs.
Measured: At CPET visit.
Secondary outcomes (2)
Change in RV (Residual Volume) and TLC (Total Lung Capacity)
We will compare change in RV and TLC during the CPET between the obese asthma patients with MD or without MD and between the patients with severe asthma with mucus plugs or without mucus plugs.
Measured: At CPET Visit
Change in oxygen saturation during exercise
Change in oxygen saturation during the CPET will be assessed and compared between the obese asthma patients with MD or without MD and between the patients with severe asthma with mucus plugs or without mucus plugs.
Measured: At CPET Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start5 Apr 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
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 University of California, San FranciscoThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- John Fahy, MD, MS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757583
- Sponsor's protocol ID
- 22-37338
- Other IDs
- R01HL164787
- Acronym
- IMAP
- Status last verified
- Jul 2026
- First submitted
- 23 Feb 2023
- Last updated
- 14 Jul 2026
- 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 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Metabolic Dysfunction and Mucus Plugging on Asthma Physiology
- ClinicalTrials.gov ID
- NCT05757583
- Acronym / sponsor ID
- IMAP / 22-37338
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 7 Mar 2023 (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.
This is a single-center study of 80 subjects with asthma including those with obesity and metabolic dysfunction (MD), those with obesity and without metabolic dysfunction, those with severe asthma and mucus plugging and those with severe asthma and without mucus plugging. Screening data will be reviewed to determine participant eligibility. Participants who meet all inclusion criteria will participate in a cardiopulmonary exercise testing (CPET) visit to compare lung function markers and change in oxygen saturation between obese patients with and without MD and severe asthma patients with and without mucus plugging.
Detailed description
The mechanism of poor exercise tolerance in patients with severe asthma is poorly understood. In preliminary data, the investigators have identified increases in air trapping in patients with obese asthma and metabolic dysfunction and patients with asthma and mucus plugs. The investigators have also found air trapping on CT (Computerized Tomography) scans of severe asthma patients with mucus plugs. Therefore, the investigators hypothesize that obese patients with metabolic dysfunction (MD) and severe asthma patients with mucus plugs develop changes in lung function during exercise.
To test this hypothesis, this protocol will plan for cardiopulmonary exercise testing in patients with obesity or severe asthma. The analyses will compare dynamic hyperinflation, expiratory flow limitation, and the RV/TLC ratio (ratio of residual volume to total lung capacity) before and after exercise between obese patients with and without MD and severe asthma patients with and without mucus plugs.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with asthma, obesity and metabolic dysfunction | – | –Otherwise healthy asthmatic subjects with: 1. Body Mass Index (BMI) ≥ 30; and 2. Metabolic dysfunction evidenced by at least one of the following: * high plasma IL-6 (> 3.0 pg/mL) * insulin resistance (HOMA-IR > 3 mass units) |
| Patients with asthma, obesity and no metabolic dysfunction | – | –Otherwise healthy asthmatic subjects with: 1. Body Mass Index (BMI) ≥ 30; and 2. No evidence of metabolic dysfunction |
| Patients with severe asthma and mucus plugs | – | –Otherwise healthy asthmatic subjects: 1. Requiring treatment with high dose inhaled corticosteroids plus a second controller, systemic corticosteroid, or biologic therapy; and 2. Evidence of mucus plugs as defined by a mucus plug score ≥ 4 |
| Patients with severe asthma and no mucus plugs | – | –Otherwise healthy asthmatic subjects: 1. Requiring treatment with high dose inhaled corticosteroids plus a second controller, systemic corticosteroid, or biologic therapy; and 2. No evidence of mucus plugs as defined by a mucus plug score < 4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will recruit up to 80 asthma participants, at least 20 with obesity and MD, 20 with obesity and no MD, 20 with severe asthma and mucus plugs and 20 with severe asthma and no mucus plugs.
Key inclusion criteria (7 listed)
- Male or female ≥ 18 years old at Visit 0
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- History of physician diagnosed asthma
- Evidence of bronchodilator reversibility (12% improvement in FEV1 after albuterol administration) or positive methacholine challenge PC20 or PD20. Historical evidence is accepted.
- Meets criteria for obesity or severe asthma a. Obesity: BMI≥30 i. Metabolic dysfunction is defined as presence of either:
Key exclusion criteria (7 listed)
- Asthma exacerbation or URI within the previous 6 weeks.
- History of smoking
- Pregnancy
- Absolute or relative contraindication to exercise testing per ATS criteria
- Any other criteria that place the subject at unnecessary risk according to the judgment of the Principal Investigator and/or attending physician of record.
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
Change in EELV (End Expiratory Lung Volume)
Time frame: At CPET visit.
We will compare change in EELV during the CPET (Cardiopulmonary Exercise Test) between the obese asthma patients with MD or without MD and between the patients with severe asthma with mucus plugs or without mucus plugs.
2 secondary outcomes
Change in RV (Residual Volume) and TLC (Total Lung Capacity)
Time frame: At CPET Visit
Change in oxygen saturation during exercise
Time frame: At CPET Visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- 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.
John Fahy, MD, MS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by University of California, San Francisco at 1 site 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 7 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in EELV (End Expiratory Lung Volume) (time frame: At CPET visit.). 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 14 Jul 2026.