A Phase 1 interventional study of Segmental allergen challenge in Allergic Asthma, Allergy to Cats and Allergy to Dust Mites, sponsored by JOSALYN CHO. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-08-31.
Sponsored by JOSALYN CHO · Phase 1, Interventional, and Basic science
Most asthma is allergic in origin. The purpose of this study is to better understand the airway immune response to inhaled allergens in order to identify factors that promote asthma.
Allergy is the strongest risk factor for asthma, and most cases of asthma are allergic in origin. However, not all allergic patients have asthma. In this study, we will enroll allergic adults to undergo bronchoscopic segmental allergen challenge in order to identify differences in the airway immune response to allergen in those with asthma compared to those without asthma. After a discussion about the study and potential risks, subjects giving written informed consent will undergo two bronchoscopies. During the first procedure, samples will be collected from the left lung and allergen will be administered to a small segment of the right lung. The second procedure will be performed 24 hours later, with collection of samples from the allergen-challenged lung segment.
45 studies on the registry are indexed under Dust Mite Allergy; 6 are open to participants now.
This study's enrollment of 12 is below the median of 68 across 35 interventional studies indexed under Dust Mite Allergy.
Browse Dust Mite Allergy studies →This is the only study on the registry with JOSALYN CHO as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Individuals who meet all of the following criteria are eligible for enrollment as study participants:
Clinical history of at least one of the following reactions to cat dander or dust mite:
In addition to inclusion criteria 1-8 above, allergic asthmatic participants must meet all of the following criteria:
In addition to inclusion criteria 1 - 8 above, allergic non-asthmatic control participants must meet all of the following criteria:
Exclusion Criteria:
Individuals who meet any of these criteria are not eligible for enrollment as study participants:
Laboratory values within 12 weeks prior to Study Visits #1 and #2 that demonstrate:
In addition to exclusion criteria 1-20 above, allergic asthmatic participants who meet any of these criteria are not eligible for enrollment as study participants:
In addition to exclusion criteria 1-20 above, allergic non-asthmatic control participants who meet any of these criteria are not eligible for enrollment as study participants:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allergic individuals with and without asthma will be enrolled.
Biological: Segmental allergen challenge
All subjects will undergo bronchoscopy with administration of standardized allergen extract to one segment of the lung.
Dendritic cell number and phenotype
Number, type and activation state of dendritic cells isolated from lung washes and brushings
Time frame: 18 months
Dendritic cell function
Ability of dendritic cells isolated from lung washes to promote T activation (measured by % proliferated)
Time frame: 18 months
Immune composition of the airway
Number and type of cluster of differentiation 45 (CD45)-expressing cells from lung brushings
Time frame: 18 months
Mediators of organized airway immune tissue formation
Mediator levels in lung washes
Time frame: 18 months
Organized airway immune tissue
Quantity of organized immune tissue in airway biopsies (measured by mm\^3)
Time frame: 18 months
Antibodies in lung washes
Quantification of immunoglobulin E (IgE) and immunoglobulin G (IgG) in lung washes
Time frame: 18 months
Antibodies in blood
Quantification of IgE and IgG in blood
Time frame: 18 months
Cytokines
Quantification of type 2 cytokines in lung washes
Time frame: 18 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2021 to primary completion in Apr 2023, 17 months.
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This study is active, not recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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