Diagnostic Procedures for Asthma

Overseen By Benjamin D Medoff, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Benjamin Medoff

Must not be taking: Antihistamines, 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: Unknown

313 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand asthma better by studying various airway factors that might cause inflammation and breathing issues. Researchers will gather data using procedures such as bronchoalveolar lavage (washing out the lungs), bronchoscopy (examining the airways with a camera), and segmental allergen challenge (exposing the lungs to allergens). Suitable candidates for this trial are adults with allergic asthma who react to cat or dust mite allergens and have smoked no more than a few packs of cigarettes in their lifetime. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking asthma research.

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

Yes, you may need to stop certain medications. The trial excludes participants who have used antihistamines within 7 days, systemic steroids, increased inhaled steroids, beta blockers, MAO inhibitors, and certain other medications within a month before the screening visit.

What prior data suggests that these diagnostic procedures are safe for asthma patients?

Research has shown that a segmental allergen challenge is safe for studying allergic asthma. Studies confirm its safety even when repeated with the same person. This method involves introducing allergens directly into the lungs to observe their reaction. It provides a controlled way to study asthma without causing harm. For those considering joining a trial using this technique, evidence suggests it is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for new diagnostic procedures for asthma because it explores innovative methods to understand this condition better. Unlike standard tests that often involve spirometry or peak flow measurements, this trial uses bronchoalveolar lavage and bronchoscopy to directly examine the lungs. These methods allow for a closer look at how allergens affect lung tissues, offering a more detailed picture of asthma's underlying mechanisms. By challenging the lungs with specific allergens, researchers aim to differentiate between allergic asthmatics, allergic nonasthmatics, and healthy individuals, potentially leading to more personalized and effective treatments in the future.

What evidence suggests that these diagnostic procedures are effective for asthma?

This trial will use segmental allergen challenge to study airway inflammation in adults who are allergic asthmatics, allergic nonasthmatics, or healthy controls. Research has shown that testing specific allergens can enhance understanding of asthma by inducing airway inflammation. Studies have found that certain proteins, such as CCL18 and YKL-40, increase during this inflammation. These proteins might influence the long-term effects of asthma on the airways. This method also predicts the effectiveness of new asthma treatments by accurately mimicking airway inflammation. This information is crucial for developing better asthma therapies. ^{5 6 7 8 9}

Who Is on the Research Team?

Benjamin D Medoff, MD, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for people aged 18-50 who are generally healthy but have allergies to cat dander or dust mites, confirmed by a positive allergy test. They should not smoke and must have normal lung function. Pregnant women, those on certain medications, with recent respiratory infections or other lung diseases, or a history of severe asthma attacks are excluded.

Inclusion Criteria

Willing and able to give informed consent

Your lung function test shows that you can breathe out at least 75% of what is expected for someone your age and size.

You have a history of allergies to cats, dust mites, or seasonal allergies.

Exclusion Criteria

You have a positive skin-prick test reaction to a specific allergen at a certain concentration.

You are likely to not follow the study rules well.

I am pregnant, not using birth control, trying to get pregnant, or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Segmental Allergen Challenge

Participants receive segmental allergen challenge to the lung to study inflammatory responses

1 week

Follow-up

Participants are monitored for safety and effectiveness after the allergen challenge

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Broncheoalveolar Lavage
• Bronchoscopy
• Segmental Allergen Challenge

Trial Overview The study aims to understand the biological factors causing airway inflammation in asthma patients through procedures like bronchoscopy and broncheoalveolar lavage after exposing participants' lungs to allergens they're sensitive to.

How Is the Trial Designed?

Group I: allergic asthmatic, allergic nonasthmatic, healthy Experimental Treatment 1 Intervention

Adults who are allergic asthmatics, allergic nonasthmatics, or healthy controls will receive segmental allergen challenge to the lung

Who Is Running the Clinical Trial?

Benjamin Medoff

Lead Sponsor

Trials

1

Recruited

310+

U.S. Army Medical Research and Development Command

Collaborator

Trials

296

Recruited

249,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3623278/

Segmental Allergen Challenge Enhances Chitinase ... Our results suggest that CCL18 and YKL-40 levels and CHIT1 activity are enhanced in allergic airway inflammation and thus may contribute to airway remodeling ...

2. atsjournals.org atsjournals.org/doi/full/10.1164/rccm.201310-1825OC

American Journal of Respiratory and Critical Care Medicine Methods: Eleven volunteers with allergic asthma and five healthy volunteers underwent segmental challenges with different allergen doses by two ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/all.15817

Standardization of clinical outcomes used in allergen ... Allergen challenge (AC) is a valuable tool which is capable of inducing airway inflammation by triggering the T2-pathway resulting in the ...

4. jacionline.org jacionline.org/article/S0091-6749(22)00080-X/abstract

Which patients with asthma are most likely to benefit from ... The bronchial allergen challenge model has demonstrated excellent negative predictive value for the development of new therapies for asthma.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S009167492200080X

Which patients with asthma are most likely to benefit from ... The bronchial allergen challenge model has demonstrated excellent negative predictive value for the development of new therapies for asthma.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/18028992/

Safety of segmental allergen challenge in human allergic ... Conclusions: Segmental allergen challenge is a safe tool to study the mechanisms of human allergic asthma, even when repeated challenges are performed in the ...

7. jacionline.org jacionline.org/article/S0091-6749(07)01659-4/fulltext

Safety of segmental allergen challenge in human allergic ... Segmental allergen challenge is a safe tool to study the mechanisms of human allergic asthma, even when repeated challenges are performed in the same patient.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0091674907016594

Safety of segmental allergen challenge in human allergic ... Segmental allergen challenge is a safe tool to study the mechanisms of human allergic asthma, even when repeated challenges are performed in the same patient.

9. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0051963

Safety of and Cellular Response to Segmental ... In mild allergic asthma, segmental allergen bronchoprovocation, using individualized doses of aeroallergens, was safe and yielded similar ...