Metabolic Dysfunction and Mucus Plugging for Asthma

(IMAP Trial)

Overseen By John Fahy, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: Inhaled corticosteroids

Disqualifiers: Recent asthma exacerbation, Smoking history, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the effects of obesity, metabolic issues, and mucus buildup on asthma. Researchers will use cardiopulmonary exercise testing to assess lung function and oxygen levels in people with asthma. The trial seeks participants with asthma who also experience obesity or severe asthma and have noticeable symptoms like mucus buildup. By revealing how these factors impact asthma, this trial could improve treatments. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to better asthma management strategies.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that cardiopulmonary exercise testing is safe for asthma patients?

Research shows that Cardiopulmonary Exercise Testing (CPET) is generally safe. Studies indicate a very low risk of serious problems. For instance, one study found major issues in only 0.6% of tests and minor issues in 9.3% of tests. Importantly, no deaths or heart attacks were reported within 48 hours after testing.

Another source mentions that the chance of death from CPET is between 2 and 5 out of every 100,000 tests. This indicates that CPET is well-tolerated and considered safe, even for individuals with heart conditions.

In summary, CPET has a strong safety record. While small risks exist, the procedure is generally safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cardiopulmonary Exercise Testing (CPET) for asthma because it provides a unique way to assess how metabolic dysfunction and mucus plugging affect asthma physiology. Unlike traditional asthma treatments that focus on controlling symptoms with inhalers or medications, CPET measures how well the lungs, heart, and muscles work together during exercise. This comprehensive approach can reveal underlying issues that typical treatments might overlook, potentially leading to more personalized and effective management strategies for asthma patients.

What evidence suggests that cardiopulmonary exercise testing is effective for asthma?

Research shows that cardiopulmonary exercise testing (CPET) safely and reliably assesses heart and lung function during exercise. It helps doctors understand heart and lung fitness. Studies have found that CPET provides important information to assess health risks and guide treatment choices. While it doesn't directly treat asthma, it evaluates how asthma affects exercise ability. This information is crucial for personalizing asthma care, especially for patients with complex issues like obesity or mucus buildup. ^{4 6 7 8 9}

Who Is on the Research Team?

John Fahy, MD, MS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

Inclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Cardiopulmonary Exercise Testing (CPET)

Participants undergo CPET to compare lung function markers and changes in oxygen saturation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after CPET

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cardiopulmonary Exercise Testing

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7807922/

Cardiopulmonary exercise testing—a beginner's guide to ... In this example, the CPET software predicted a maximum work of 178 W and the patient achieved a maximum of 221 W during the test (124%). (ii). Achieving a HR of > ...

2. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.038200

Cardiopulmonary Exercise Test Interpretation Across the ... The presence of exercise oscillatory ventilation is associated with 3.9 times increased hazard of death, transplant, and nonelective ...

3. atsjournals.org atsjournals.org/doi/10.1164/rccm.167.2.211

ATS/ACCP Statement on Cardiopulmonary Exercise Testing CPET is a safe procedure, with the risk of death for patients between 2 and 5 per 100,000 exercise tests performed. For all tests, attention to patient safety ...

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0328056

A cohort study based on routinely collected data | PLOS One Cardiopulmonary exercise testing (CPET) provides objective measures of cardiorespiratory fitness and can support surgical risk stratification. As socioeconomic ...

5. respiratory-research.biomedcentral.com respiratory-research.biomedcentral.com/articles/10.1186/s12931-021-01895-6

Practical guide to cardiopulmonary exercise testing in adults This article describes the underlying principles of exercise physiology and provides a practical guide to performing CPET and interpreting the results in ...

6. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.112.110460

The Safety of Cardiopulmonary Exercise Testing in a ... The 2002 American Heart Association exercise testing guidelines cite an adverse event rate of up to 0.04% or 1 per 2500 tests. ... This figure is ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23091065/

The safety of cardiopulmonary exercise testing in a ... Conclusions: CPX is generally a safe procedure, even in a population with underlying high-risk cardiovascular diagnoses. MeSH terms. Adult; Aged ...

8. academic.oup.com academic.oup.com/eurheartj/article/44/Supplement_2/ehad655.1933/7393276

Safety of cardiopulmonary exercise testing in a large ... A major event occurred in 56 (0.6%) tests and a minor event in 870 (9.3%) tests. There were no deaths within 48 hours, nor cardiac arrests ...

9. jacc.org jacc.org/doi/full/10.1016/S0735-1097(18)31434-7

UTILITY AND SAFETY OF CARDIOPULMONARY ... CPET appears to be a safe and excellent predictive tool for risk stratification in patients with HCM regardless of severity of resting left ...