Understanding Immune Cell Response in Asthma

Overseen By Rod A Rahimi, MD PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Andrew D. Luster, M.D.,Ph.D.

Must be taking: Inhaled corticosteroids

Must not be taking: Antihistamines, Systemic steroids, Beta blockers, MAO inhibitors

Disqualifiers: Pregnancy, Diabetes, Heart failure, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how certain immune cells in the lungs react to allergens in people with allergic asthma. By studying these cells, researchers hope to discover new ways to improve asthma treatments. Participants will undergo procedures like airway brushing (a technique to collect cells from the airways) and bronchoscopy/BAL (bronchoalveolar lavage, a procedure to examine the lungs) to gather data. This trial suits individuals with mild to moderate allergic asthma who react to indoor allergens like cats, dogs, or dust mites and do not smoke.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to innovative asthma treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot use certain medications like systemic steroids, beta blockers, or specific biologics within certain time frames before the study. If you are on daily inhaled corticosteroids, you may continue them if they are within the allowed dose.

What prior data suggests that these procedures are safe for participants?

Research has shown that both airway brushing and bronchoscopy with bronchoalveolar lavage (BAL) are generally safe procedures, even for people with asthma.

Studies indicate that airway brushing safely collects cells from the airways. However, its safety specifically for individuals with asthma hasn't been fully explored, so some unknown risks may exist, particularly for those with asthma or chronic bronchitis.

Bronchoscopy with BAL is considered safe for people with asthma. Some studies have noted minor complications, such as coughing, which is usually not severe. Occasionally, individuals might experience slight shortness of breath or discomfort, but serious problems are rare.

Overall, both procedures are well-tolerated. Participants should discuss any concerns with their doctors before joining a study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how immune cells respond in asthma by using techniques like airway brushing and bronchoscopy/BAL. Unlike standard treatments that focus on managing symptoms with medications like inhaled corticosteroids or bronchodilators, this study aims to directly observe and understand the cellular mechanisms in the airways. By gaining insights into the immune cell dynamics, researchers hope to uncover new therapeutic targets that could lead to more effective treatments for asthma in the future.

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

Research has shown that focusing on certain immune cells, called memory Th2 cells, might help treat allergic asthma. Th2 cells, part of the immune system, contribute to the inflammation in asthma. In this trial, participants will undergo procedures like bronchoscopy and bronchoalveolar lavage (BAL) to study lung inflammation. Studies involving airway brushing have revealed that the lining of the airways is crucial in asthma because it triggers immune responses. These responses can worsen asthma symptoms. Research using BAL has found that specific immune cells, such as lymphocytes and eosinophils, are active in asthma. Understanding how these cells function could lead to better asthma treatments. ^{6 7 8 9 10}

Who Is on the Research Team?

Andrew D Luster

Principal Investigator

MGH

Are You a Good Fit for This Trial?

This trial is for adults aged 18-55 with allergic asthma, who've never smoked much (less than 5 pack-years and none in the past 5 years), have a certain level of lung function, react to indoor allergens like pet dander or dust mites, and are not pregnant or nursing. People can't join if they're on certain medications, have other lung diseases, severe allergies to specific drugs used in the study, recent infections or steroid use.

Inclusion Criteria

Willing and able to give informed consent.

I am willing to talk with the lead researcher.

You will need to have a positive test for methacholine challenge with a PC20 less than 16 mg/ml.

Exclusion Criteria

I have been intubated due to severe asthma in the past.

Subjects with a high possibility of poor compliance with the study.

I haven't used steroids, beta blockers, or MAO inhibitors for asthma in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Bronchoscopy and Airway Brushing

Participants undergo bronchoscopy and airway brushing to collect samples for analysis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Airway Brushing
• Bronchoscopy/BAL

Trial Overview

The study investigates how memory Th2 cells in the lungs respond to common airborne allergens by performing bronchoscopy/BAL and airway brushing on participants. It aims to understand these cells' role in allergic reactions which could lead to new treatments for allergic asthma.

How Is the Trial Designed?

Group I: Allergic Asthmatic or Healthy Control Adults Experimental Treatment 2 Interventions

Allergic Asthmatic or Healthy Control Adults will undergo Bronchoscopy/BAL and airway brushing

Who Is Running the Clinical Trial?

Andrew D. Luster, M.D.,Ph.D.

Lead Sponsor

Trials

3

Recruited

250+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Published Research Related to This Trial

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]

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]

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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In asthma, the inflammatory response precipitates the epithelial injury and drives abnormal basal cell differentiation. This leads to reduced ciliated cells, ...

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Here, we review the role of the airway epithelium in severe asthma and how targeting the epithelium can contribute to asthma treatment.