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

Trial Summary

What is the purpose of this trial?

The objective of this pilot study is to determine whether obesity and metabolic syndrome are in fact synergistic in relation to airway nitric oxide (NO) biology. To do so, the investigators want to determine how obesity and the metabolic syndrome relate to metabolism in bronchial airway epithelial cells and the nasal epithelium.

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 data supports the effectiveness of the treatment Bronchoscopy, Bronchoscopy, Flexible Bronchoscopy, Nasal Epithelium Brush Sampling in asthma?

The research indicates that bronchoscopy and related procedures can be safely performed in patients with asthma, which is important for identifying specific asthma types and guiding personalized treatment. This suggests that these procedures are effective in helping tailor asthma management to individual needs. ^{1 2 3 4 5}

Is bronchoscopy safe for people with asthma?

Bronchoscopy and related procedures like bronchoalveolar lavage and bronchial biopsies are generally safe for people with asthma, though some may experience mild side effects like chest pain, shortness of breath, or flu-like symptoms. Most complications occur when bronchoalveolar lavage is performed, but serious issues are rare. ^{1 6 7 8 9}

How does this treatment for asthma differ from other treatments?

This treatment involves using a fiberoptic bronchoscopy with bronchoalveolar lavage (BAL) and endobronchial biopsy, which is a procedure to examine the airways and collect samples, rather than a medication. It is unique because it allows for direct observation and sampling of the lungs, which can help understand metabolic changes in asthma, unlike standard drug treatments that primarily focus on symptom relief. ^{2 3 10 11 12}

Research Team

Fernando Holguin, MD, MPH

Principal Investigator

University of Colorado Denver, Anschutz Medical Campus

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety of bronchoalveolar lavage and bronchial biopsies in patients with asthma of variable severity. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

The safety aspects of fiberoptic bronchoscopy, bronchoalveolar lavage, and endobronchial biopsy in asthma. [2015]

3. United States 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. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Importance of fiberoptic bronchoscopy in identifying asthma phenotypes to direct personalized therapy. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Bronchoalveolar lavage. Its safety in subjects with mild asthma. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Safety of research bronchoscopy, biopsy and bronchoalveolar lavage in asthma. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Safety and cellular assessment of bronchial brushing in airway diseases. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Investigative bronchoprovocation and bronchoscopy in airway diseases. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Safety of fibreoptic bronchoscopy in asthmatic and control subjects and effect on asthma control over two weeks. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Effects of bronchoscopy on lung function in asthmatics. [2019]

11. Japan pubmed.ncbi.nlm.nih.gov

Serial Epithelial Lining Fluid Collection Using Bronchoscopic Microsampling in a Canine Lung Transplantation Model. [2017]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Breathomics in Asthmatic Children Treated with Inhaled Corticosteroids. [2020]