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Understanding Immune Cell Response in Asthma
N/A
Recruiting
Led By Andrew D Luster
Research Sponsored by Andrew D. Luster, M.D.,Ph.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age between 18 and 55 years.
Life-long absence of cigarette smoking (lifetime total of < 5 pack-years and none in 5 years).
Must not have
A history of asthma-related respiratory failure requiring intubation.
Women of childbearing potential who are pregnant (based on urine beta-HCG testing), are sexually active and not using contraception, are seeking to become pregnant or who are nursing.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up this is a single time point study with all information obtained at the time of bronchoscopy defined as day 0.
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying how well memory T helper type 2 cells work to initiate a recall response to aeroallergens in the lungs.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects from procedures may include discomfort during bronchoscopy such as coughing or wheezing; sore throat; bleeding; infection risk; reaction to sedatives like fentanyl or midazolam used during the procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 55 years old.
Select...
I have smoked less than 5 packs of cigarettes in my life and none in the last 5 years.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been intubated due to severe asthma in the past.
Select...
I am not pregnant, trying to get pregnant, or nursing, and I use contraception if sexually active.
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I have diabetes, heart failure, arrhythmias, stroke history, kidney failure, severe allergies, or liver cirrhosis.
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I haven't used specific asthma or other condition treatments like Nucala, Cinqair, Fasenra, or Dupixent in the last 6 months.
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I haven't smoked cigarettes in the last 5 years and have smoked less than 5 pack-years in total.
Select...
I do not have other lung conditions like sarcoidosis or active infections.
Select...
I have not used Xolair in the last 6 months.
Select...
I am currently taking beta-blockers or MAO inhibitors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ this is a single time point study with all information obtained at the time of bronchoscopy defined as day 0.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~this is a single time point study with all information obtained at the time of bronchoscopy defined as day 0.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The phenotype of Th2-Trm recovered from the airway mucosa
The transcriptional profile of Th2-Trm recovered from the airway mucosa
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Allergic Asthmatic or Healthy Control AdultsExperimental Treatment2 Interventions
Allergic Asthmatic or Healthy Control Adults will undergo Bronchoscopy/BAL and airway brushing
Find a Location
Who is running the clinical trial?
Andrew D. Luster, M.D.,Ph.D.Lead Sponsor
2 Previous Clinical Trials
211 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,319 Previous Clinical Trials
5,548,040 Total Patients Enrolled
Andrew D LusterPrincipal InvestigatorMGH
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been intubated due to severe asthma in the past.I haven't used steroids, beta blockers, or MAO inhibitors for asthma in the last month.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.I am not pregnant, trying to get pregnant, or nursing, and I use contraception if sexually active.I have diabetes, heart failure, arrhythmias, stroke history, kidney failure, severe allergies, or liver cirrhosis.I haven't used specific asthma or other condition treatments like Nucala, Cinqair, Fasenra, or Dupixent in the last 6 months.Your breathing test results need to be at least 75% of what is expected for someone your age and size.You have a history of allergic reactions to indoor allergens like cats, dogs, or dust mites, and a positive skin test for the same allergen.I haven't taken antibiotics for lung issues in the last month or had a lung infection in the last 6 weeks.I haven't smoked cigarettes in the last 5 years and have smoked less than 5 pack-years in total.I am not exposed to indoor animals or second-hand smoke.I do not have other lung conditions like sarcoidosis or active infections.I am between 18 and 55 years old.I have smoked less than 5 packs of cigarettes in my life and none in the last 5 years.You have received treatment for allergies to cats, dogs, or dust mites in the past 10 years.I've had an asthma flare-up or a cold in the last 6 weeks without changing my asthma medicine.I have not used Xolair in the last 6 months.I haven't taken antihistamines in the last 7 days.I am currently taking beta-blockers or MAO inhibitors.You are unable to tolerate certain medications like albuterol, atropine, lidocaine, fentanyl, or midazolam.
Research Study Groups:
This trial has the following groups:- Group 1: Allergic Asthmatic or Healthy Control Adults
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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