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Allergen Challenge for Asthma

Phase 1
Waitlist Available
Led By Josalyn L Cho, MD
Research Sponsored by JOSALYN CHO
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
In addition to inclusion criteria 1-8 above, allergic asthmatic participants must meet all of the following criteria: Clinical history of asthma, Asthma severity requiring no more than step 2 therapy, Validated asthma control test (ACT) score of > 19 at Screening Visit #1, Able to tolerate a 2-week stoppage of inhaled corticosteroids prior to Screening Visit #2 and both Study Visits, Baseline forced expiratory volume in 1 second (FEV1) no less than 75% of the predicted value after bronchodilator administration, Methacholine provocative concentration 20 (PC20) < 16 mg/ml
Age between 18 and 50 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Study Summary

This trial is studying the airway immune response to inhaled allergens in people with and without asthma to see what promotes the disease.

Who is the study for?
This trial is for non-smoking women and men aged 18-50 with allergic reactions to cat dander or dust mites, like nasal congestion or eye irritation. Women must use effective birth control. People with asthma can join if it's mild and controlled. You can't join if you smoke, have other lung diseases, take certain medications recently, have serious health issues like heart failure or liver disease, are pregnant or breastfeeding, don't speak English, or used allergy shots.Check my eligibility
What is being tested?
The study aims to understand how the immune system in the airways responds when people with allergies breathe in allergens. It involves a procedure called segmental allergen challenge where an allergen is introduced directly into a lung segment to observe the response.See study design
What are the potential side effects?
Possible side effects from the segmental allergen challenge may include temporary increased allergic symptoms such as sneezing, coughing, wheezing, shortness of breath or chest tightness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
If you have allergic asthma, your asthma should not be severe, you should have good control over your asthma, and you should be able to stop using inhaled corticosteroids for at least two weeks before the study. Your lung function should be relatively good, and your body should not react strongly to methacholine.
Select...
I am between 18 and 50 years old.
Select...
I have smoked less than 10 pack-years in my life and none in the past year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dendritic cell function
Dendritic cell number and phenotype
Immune composition of the airway
+2 more
Secondary outcome measures
Antibodies in blood
Antibodies in lung washes
Cytokines

Trial Design

1Treatment groups
Experimental Treatment
Group I: Segmental allergen challengeExperimental Treatment1 Intervention
Allergic individuals with and without asthma will be enrolled.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalOTHER
2,928 Previous Clinical Trials
13,198,343 Total Patients Enrolled
JOSALYN CHOLead Sponsor
Josalyn L Cho, MDPrincipal InvestigatorUniversity of Iowa

Media Library

Segmental allergen challenge Clinical Trial Eligibility Overview. Trial Name: NCT04619017 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation inviting elderly individuals to be participants?

"This trial is primarily intended for those between 18 and 50 years old. However, there are additional trials catering to younger patients (210) and the elderly demographic (393)."

Answered by AI

Is this research endeavor currently open to new participants?

"Indeed, the clinicaltrials.gov portal indicates that this trial is actively searching for patients as of May 26th 2022. The study was initially posted on March 1st and seeks a total of 12 participants from 2 sites."

Answered by AI

Does the Federal Drug Administration acknowledge Segmental allergen challenge?

"Considering there is limited data available backing the safety and efficacy of Segmental allergen challenge, our team at Power deemed it a 1 on its risk scale."

Answered by AI

What is the current scale of this experiment's patient base?

"Affirmative. Clinicaltrials.gov documents indicate that this clinical trial is actively recruiting participants, and was initially advertised on March 1st 2022 before its most recent update on May 26th 2022. Two medical sites are combining to enroll a total of 12 patients for the study."

Answered by AI

Do I qualify to partake in this research initiative?

"This clinical investigation is recruiting 12 individuals between 18 and 50 years old, who have rhinitis. In addition to that requirement, patients must not have any history of smoking or vaping in the last year; display allergic conjunctivitis symptoms like itching, tearing or swelling; exhibit urticarial reactions when coming into contact with cats; possess a diagnosis of asthma; as well as maintain an absence from cigarette usage for at least 10 cumulative pack-years without having smoked within the prior twelve months."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Airway Immune Response to Allergens (Use Lay Language Here)
JOSALYN CHO 2021. "Airway Immune Response to Allergens (Use Lay Language Here)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04619017.
~4 spots leftby Apr 2025
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