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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).
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
Study 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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The phenotype of Th2-Trm recovered from the airway mucosa
The transcriptional profile of Th2-Trm recovered from the airway mucosa
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
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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
3,269 Previous Clinical Trials
5,481,349 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open enrollments for this research study at the moment?
"As evidenced by clinicaltrials.gov, this study is currently recruiting participants and was first made public on May 23rd 2019 before being updated most recently on September 6th 2022."
Answered by AI
Is the age requirement for this experiment limited to those below 60 years old?
"To be accepted for this trial, the patient must fall between 18 and 55 years of age. In addition, there are 117 studies specifically tailored towards minors and 199 clinical trials designed to meet the needs of senior citizens."
Answered by AI
How can I sign up to participate in this experiment?
"This medical study requires 120 participants aged between 18 to 55 with asthma. To meet the requirements, those enrolled must have a baseline FEV1 of at least 75% their predicted value and take twice daily inhaled corticosteroids (ICS) dose capped at 220MCG fluticasone or equivalent ICS. Furthermore, they never smoked cigarettes for more than 5 pack-years in life and are willing to be interviewed by the lead researcher. Lastly, mild to moderate allergic asthma sufferers will also qualify for participation in this trial"
Answered by AI
What is the sample size for this research project?
"That is correct. The details available on clinicaltrials.gov denote that recruiting for this experiment began on May 23, 2019 and the information was most recently revised on September 6th 2022. This trial requires 120 participants from a single location to partake in it."
Answered by AI
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