Metabolic Changes in Asthma

Overseen By Asthma Research

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Statins, Diabetic medications

Disqualifiers: Heart disease, Cancer, Diabetes, others

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

Compensation: Varies

Number of Visits: 4

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how obesity and metabolic syndrome (a group of conditions like high blood pressure and high blood sugar) affect the airways in people with asthma. Researchers will study cells from the nose and lungs to determine how these conditions might change breathing. Participants will undergo procedures such as bronchoscopy, where a small camera examines the airways, and nasal brush sampling to collect cells. The trial seeks individuals with asthma and a BMI of 30 or higher, particularly those with metabolic syndrome. As an unphased trial, this study offers a unique opportunity to contribute to understanding asthma in the context of obesity and metabolic syndrome.

Do I need to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using statins or diabetic medications.

What prior data suggests that bronchoscopy and nasal epithelium brush sampling are safe?

Research has shown that both bronchoscopy and nasal epithelium brush sampling are generally safe procedures. Studies have found that bronchoscopy is well-tolerated by individuals with and without asthma. For example, one study noted a slight decrease in lung function, measured by peak expiratory flow rate (PEFR), in both groups after the procedure, but it was not concerning.

Nasal epithelium brush sampling is also considered safe and is less invasive than some other methods. This procedure involves gently collecting cells from the nose for study and usually causes only minor discomfort.

These procedures have proven safe for research, even for individuals with asthma, making them reliable for studies like this one. However, as with any medical procedure, minor risks or discomforts might occur, but these are generally well-managed in clinical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how metabolic changes impact asthma, which is a fresh angle compared to traditional asthma treatments like inhalers and corticosteroids. Traditional treatments focus on managing symptoms and reducing inflammation, but this study is diving into how obesity and metabolic syndrome might alter asthma at a cellular level. By using bronchoscopy and nasal epithelium brush sampling, scientists can directly observe the airway cells and potentially uncover new insights into how asthma behaves in different body types. This approach could lead to more personalized and effective treatment strategies in the future.

What evidence suggests that this trial's treatments could be effective for asthma?

In this trial, participants will undergo bronchoscopy and nasal epithelium brush sampling to gather data on metabolic changes in asthma. Research has shown that bronchoscopy, a procedure to look inside the airways, is usually safe for people with asthma and can help doctors better understand and manage the condition. However, it might sometimes worsen symptoms in severe cases. For nasal epithelium brush sampling, which collects cells from the nose, studies have shown it can detect signs of asthma by examining changes in these cells, which often mirror lung changes. This method helps researchers learn more about asthma and could lead to more personalized treatments. While both procedures provide valuable information, they are not treatments for asthma but tools to gather data. ^{1 3 6 7 8}

Who Is on the Research Team?

Fernando Holguin, MD, MPH

Principal Investigator

University of Colorado Denver, Anschutz Medical Campus

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with asthma, obesity (BMI ≥ 30), and possibly metabolic syndrome. Asthmatics must have had a diagnosis for over 6 months, non-smokers for at least a year, and certain lung function criteria. People with recent respiratory issues, hospital visits due to asthma, or on specific medications like corticosteroids or statins cannot join.

Inclusion Criteria

My lung function is good and I'm overweight, but I don't have metabolic syndrome.

I have smoked less than 10 pack-years and not in the past year.

I have been diagnosed with metabolic syndrome.

Exclusion Criteria

I do not have any major health issues like heart disease, uncontrolled diabetes, kidney problems, or severe mental health conditions.

Current or recent (within 30 days) investigational treatment or participation in another interventional research study (including non-pharmacologic interventions)

You are pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Participants undergo baseline evaluation, lung function testing, and bronchoscopy and nasal epithelial brush sampling if eligible

1-2 weeks

1 visit (in-person)

Procedure and Recovery

Participants undergo bronchoscopy and nasal epithelial brush sampling, followed by recovery and post-procedure monitoring

1 day

1 visit (in-person)

Follow-up

Participants are monitored for post-procedure clinical stability

1-2 days

2 calls (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Bronchoscopy
• Nasal Epithelium Brush Sampling

Trial Overview The study aims to understand the relationship between obesity/metabolic syndrome and airway nitric oxide in asthmatics by sampling cells from the bronchial airway epithelium and nasal epithelium through bronchoscopy.

How Is the Trial Designed?

Group I: Obese non-asthmatics Experimental Treatment 1 Intervention

BMI \>/= 30

Group II: Obese Astmatics Experimental Treatment 1 Intervention

BMI \>/= 30 and with metabolic syndrome

Group III: Obese Asthmatics Experimental Treatment 1 Intervention

BMI \>/= 30 and without metabolic syndrome

Group IV: Non - obese asthmatics Experimental Treatment 1 Intervention

BMI: lean \> 20; Normal \>/= 20 to \<25; overweight \</= 25 to \< 30;

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Jewish Health

Collaborator

Trials

145

Recruited

318,000+

Published Research Related to This Trial

In a study involving 21 asthmatic subjects, bronchoscopy resulted in a median 23% decrease in peak expiratory flow rates (PEFR) immediately after the procedure, but this drop was not significantly different from the response in non-asthmatic controls, suggesting that sedation effects may play a role rather than bronchospasm.

Monitoring of asthma control for two weeks post-bronchoscopy showed no significant changes in PEFR, symptom scores, or medication use among asthmatic patients, indicating that the procedure is well tolerated and does not adversely affect asthma management in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of fibreoptic bronchoscopy in asthmatic and control subjects and effect on asthma control over two weeks. Humbert, M., Robinson, DS., Assoufi, B., et al.[2019]

Fiberoptic bronchoscopy with bronchoalveolar lavage and endobronchial biopsy can be performed safely in asthmatic patients, although it may cause a significant drop in lung function (FEV1) immediately after the procedure, particularly in those with more responsive airways.

The procedure resulted in arterial oxygen desaturation in asthmatic subjects, but it did not significantly affect their airway responsiveness (PC20) measured before and after the bronchoscopy, indicating that while the procedure is generally safe, careful monitoring is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety aspects of fiberoptic bronchoscopy, bronchoalveolar lavage, and endobronchial biopsy in asthma. Djukanović, R., Wilson, JW., Lai, CK., et al.[2015]

Investigative bronchoscopy and bronchoprovocation remain crucial for research on lung diseases like asthma and chronic obstructive pulmonary disease, despite the emergence of less invasive techniques.

The safety of these procedures is considered acceptable for volunteers and patients, but there is a strong emphasis on the need for proper training of medical personnel and careful monitoring, especially when involving vulnerable populations like children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigative bronchoprovocation and bronchoscopy in airway diseases. Busse, WW., Wanner, A., Adams, K., et al.[2018]

This study involved 50 patients with varying severity of asthma and 25 healthy volunteers, assessing the safety of fiberoptic bronchoscopy, bronchoalveolar lavage (BAL), and bronchial biopsies without premedication using nebulized bronchodilators.

The results showed that the procedures were safe for patients with severe asthma, as the decrease in arterial oxygen saturation during the procedures was similar between asthmatic patients and healthy controls, indicating that severity of asthma did not significantly impact safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of bronchoalveolar lavage and bronchial biopsies in patients with asthma of variable severity. Van Vyve, T., Chanez, P., Bousquet, J., et al.[2013]

Bronchoscopic microsampling (BMS) is a safe and effective method for collecting epithelial lining fluid (ELF) in a canine lung transplant model, allowing for real-time monitoring without adverse effects.

The study found significantly elevated levels of TNF-α in ELF after lung reperfusion, indicating that BMS can effectively capture inflammatory responses associated with ischemia-reperfusion lung injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serial Epithelial Lining Fluid Collection Using Bronchoscopic Microsampling in a Canine Lung Transplantation Model. Oiwa, K., Kohno, M., Hashimoto, R., et al.[2017]

Phenotyping refractory asthma through direct bronchoscopic observation and analysis of bronchoalveolar lavage (BAL) and biopsies allows for personalized therapy, improving treatment outcomes.

Using fiberoptic bronchoscopy, specific asthma phenotypes can be identified, such as laryngopharyngeal reflux and tissue eosinophilia, which helps tailor effective treatments for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Importance of fiberoptic bronchoscopy in identifying asthma phenotypes to direct personalized therapy. Lommatzsch, SE., Martin, RJ., Good, JT.[2015]

The bronchoscopic microsampling (BMS) probe is a safe method for sampling the epithelial lining fluid in small airways, with no complications observed in patients during or after the procedure.

In patients with acute respiratory distress syndrome (ARDS), BMS effectively detected significantly elevated levels of inflammation-related markers, indicating its potential utility for monitoring pulmonary inflammation in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New bronchoscopic microsample probe to measure the biochemical constituents in epithelial lining fluid of patients with acute respiratory distress syndrome. Ishizaka, A., Watanabe, M., Yamashita, T., et al.[2020]

In a study involving 159 asthmatic patients who underwent 273 bronchoscopies, the procedures were found to be generally safe, with adverse events occurring in only 34 instances, none of which followed allergen challenges.

Most complications were associated with the combination of endobronchial biopsy and bronchoalveolar lavage, indicating that bronchoalveolar lavage may be responsible for the majority of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of research bronchoscopy, biopsy and bronchoalveolar lavage in asthma. Elston, WJ., Whittaker, AJ., Khan, LN., et al.[2013]

In a study of 92 subjects undergoing bronchoscopy, those with nonsevere asthma recovered lung function (FEV1 and FVC) more quickly than those with severe asthma, indicating differences in pulmonary physiology related to asthma severity.

Oral corticosteroid treatment (40mg daily for 14 days) led to a faster recovery of lung function in both nonsevere and severe asthma patients after a second bronchoscopy, suggesting that inflammation plays a significant role in lung compliance changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of bronchoscopy on lung function in asthmatics. Bellinger, C., Bleecker, ER., Peters, S., et al.[2019]

The study found that 'breathomics' can effectively distinguish between asthmatic children (26 participants) and healthy children (16 participants) by analyzing exhaled breath condensate, identifying potential biomarkers related to asthma.

Despite significant clinical improvements in asthma control and lung function after a three-week treatment with inhaled beclomethasone dipropionate, there were no changes in the metabolic profiles of exhaled breath or urine, suggesting that the treatment's efficacy may not be reflected in these specific metabolic markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breathomics in Asthmatic Children Treated with Inhaled Corticosteroids. Ferraro, VA., Carraro, S., Pirillo, P., et al.[2020]

A study involving 10 adults with mild asthma found that fiberoptic bronchoscopy and bronchoalveolar lavage (BAL) can be performed safely, with no major complications reported.

Only one subject experienced mild bronchospasm, and none of the nine asthmatic subjects who completed the procedure had clinically significant bronchospasm, indicating that the procedure is safe for individuals with mild asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bronchoalveolar lavage. Its safety in subjects with mild asthma. Rankin, JA., Snyder, PE., Schachter, EN., et al.[2019]

Bronchial brushing is a safe and well-tolerated method for collecting bronchial epithelial cells (BECs) in patients with asthma and chronic bronchitis, with no complications observed during the procedure in a study involving 70 participants.

While the procedure effectively recovers BECs, the viability of these cells is significantly lower in asthmatic and chronic bronchitis patients compared to healthy controls, indicating potential differences in cell health related to these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and cellular assessment of bronchial brushing in airway diseases. Romagnoli, M., Vachier, I., Vignola, AM., et al.[2019]

Citations

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Bronchoscopy in Severe Asthmatics: Is it a Safe Procedure? 8 found that bronchoscopy and bronchial biopsy were well tolerated in asthmatic patients with similar fall in PEFR in both asthmatics and non-asthmatics; ...

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Safety of research bronchoscopy, biopsy and bronchoalveolar ... Bronchoscopy, endobronchial biopsy and bronchoalveolar lavage can be performed safely in asthmatic patients.