ClinicalTrials.gg
Active, not recruitingNCT04619017Updated Aug 31, 2023

Airway Immune Response to Allergens (Use Lay Language Here)

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

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Allergic Asthma
  • Allergy to Cats
  • Allergy to Dust Mites
  • Allergic Rhinitis
  • Allergic Conjunctivitis

Keywords

  • asthma
  • allergy
  • allergic rhinitis
  • allergic conjunctivitis
  • cat allergy
  • house dust mite allergy
03

In context

Dust Mite Allergy

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 →

Lead sponsor

This is the only study on the registry with JOSALYN CHO as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

Individuals who meet all of the following criteria are eligible for enrollment as study participants:

  1. Participant must be able to understand and provide .
  2. Age between 18 and 50 years.
  3. Clinical history of at least one of the following reactions to cat dander or dust mite:

    1. Allergic rhinitis, with one or more of nasal congestion, sneezing, runny nose or post- nasal drainage,
    2. Allergic conjunctivitis, with one or more of ocular itching, tearing or swelling, or
    3. Urticarial reactions to contact with cats.
  4. Positive allergen prick test to the allergen causing clinical symptoms. A positive skin prick test is defined as a wheal sum 3 mm in diameter greater than diluent control.
  5. Negative urine pregnancy test at all visits for female participants of .
  6. Female participants with reproductive potential must agree to use an FDA approved method of for the duration of the study. A highly effective method of contraception is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly and includes, but is not limited to, abstinence from intercourse with a male partner, monogamous relationship with a vasectomized partner, male condoms with the use of applied spermicide, intrauterine devices, and licensed hormonal methods.
  7. Life-long absence of cigarette smoking, defined as a lifetime total of less than 10 pack-years and none in the past year.
  8. Absence of vaping, inhaling or smoking non-cigarette products in the past year.

In addition to inclusion criteria 1-8 above, allergic asthmatic participants must meet all of the following criteria:

  1. Clinical history of asthma.
  2. Asthma severity requiring no more than step 2 therapy (NHLBI Guideline, 2007 Expert Panel Report-3 (EPR-3), http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf).
  3. Validated asthma control test (ACT) score of > 19 at Screening Visit #1.
  4. Able to tolerate a 2-week stoppage of inhaled prior to Screening Visit #2 and both Study Visits.
  5. Baseline (FEV1) no less than 75% of the predicted value after bronchodilator administration.
  6. Methacholine provocative concentration 20 (PC20) \< 16 mg/ml.

In addition to inclusion criteria 1 - 8 above, allergic non-asthmatic control participants must meet all of the following criteria:

  1. Baseline FEV1 no less than 90% of the predicted value.
  2. Methacholine PC20 ≥ 16 mg/ml.

Exclusion criteria

Exclusion Criteria:

Individuals who meet any of these criteria are not eligible for enrollment as study participants:

  1. Inability or unwillingness of a participant to give written or comply with study protocol.
  2. Quantitative skin prick titration with a positive reaction to an allergen concentration of 0.056 bioequivalent allergy units (BAU) or allergy units (AU) per ml.
  3. Other lung diseases, including but not limited to sarcoidosis, bronchiectasis and active lung infection.
  4. History of a respiratory tract infection within 6 weeks of Study Visits #1 and #2.
  5. Participant reported current diagnosis or history of diabetes mellitus, congestive heart failure, ventricular arrhythmias, history of a cerebrovascular accident, renal failure, history of anaphylaxis, or liver disease.
  6. Participant reported history of coagulopathy, thrombocytopenia or pulmonary hypertension.
  7. Intolerance to albuterol, atropine, lidocaine, fentanyl, or midazolam.
  8. Laboratory values within 12 weeks prior to Study Visits #1 and #2 that demonstrate:

    1. count less than 80,000/mm3,
    2. (PT) more than 1.5 x (ULN), or
    3. Partial thromboplastin time (PTT) more than 1.5 x ULN.
  9. Females of who are documented to be pregnant (based on urine beta-human chorionic gonadotropin (b-HCG) testing), are sexually active and not using , are seeking to become pregnant, or who are breast feeding.
  10. Current or former use of targeted biological therapy for asthma or allergic disorders including but not limited to benralizumab, dupilumab, mepolizumab, omalizumab, and reslizumab.
  11. Current or past immunotherapy with cat or dust mite extract.
  12. Antibiotic use within 6 weeks of Study Visits #1 and #2.
  13. Use of systemic within 4 weeks of any Screening or Study Visit. Participants may be rescreened after completion of steroid treatment.
  14. Current use of beta blockers and monoamine oxidase (MAO) inhibitors.
  15. Current use of anti-coagulants including but not limited to apixaban, clopidogrel, dabigatran, dalteparin, danaparoid, enoxaparin, heparin, rivaroxaban, tinzaparin, and warfarin.
  16. Use of aspirin or NSAIDs and inability to stop these medications for 7 days prior to Study Visits #1 and #2.
  17. Non-English speakers.
  18. Current, diagnosed mental illness or current, diagnosed or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
  19. Use of drugs within 30 days of participation.
  20. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

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:

  1. Spontaneous asthmatic episode, defined as a worsening of asthma symptoms requiring an escalation of short-acting bronchodilators and/or inhaled corticosteroids lasting for 2 days or more, within 6 weeks of Screening Visit #1.
  2. Increased use of inhaled corticosteroids within 4 weeks of Screening Visit #1.
  3. A history of respiratory failure requiring intubation.

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:

  1. History of asthma.
Terms in these criteria, in plain language(9)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Segmental allergen challenge

    Allergic individuals with and without asthma will be enrolled.

    Biological: Segmental allergen challenge

Interventions

  • BiologicalSegmental allergen challenge

    All subjects will undergo bronchoscopy with administration of standardized allergen extract to one segment of the lung.

06

What researchers measure

Primary outcomes

  1. Dendritic cell number and phenotype

    Number, type and activation state of dendritic cells isolated from lung washes and brushings

    Time frame: 18 months

  2. Dendritic cell function

    Ability of dendritic cells isolated from lung washes to promote T activation (measured by % proliferated)

    Time frame: 18 months

  3. Immune composition of the airway

    Number and type of cluster of differentiation 45 (CD45)-expressing cells from lung brushings

    Time frame: 18 months

  4. Mediators of organized airway immune tissue formation

    Mediator levels in lung washes

    Time frame: 18 months

  5. Organized airway immune tissue

    Quantity of organized immune tissue in airway biopsies (measured by mm\^3)

    Time frame: 18 months

Secondary outcomes

  1. Antibodies in lung washes

    Quantification of immunoglobulin E (IgE) and immunoglobulin G (IgG) in lung washes

    Time frame: 18 months

  2. Antibodies in blood

    Quantification of IgE and IgG in blood

    Time frame: 18 months

  3. Cytokines

    Quantification of type 2 cytokines in lung washes

    Time frame: 18 months

07

Study locations

2 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2021 to primary completion in Apr 2023, 17 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2020
First posted
Nov 6, 2020
StartActual
Oct 28, 2021
Primary completionActual
Apr 8, 2023
CompletionEst.
Mar 1, 2024
Last update
Aug 31, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04619017
Lead sponsor
JOSALYN CHO
Responsible party
JOSALYN CHO (Assistant Professor, University of Iowa) — Sponsor-investigator
First posted
Nov 6, 2020
Start date
Oct 28, 2021
Primary completion
Apr 8, 2023
Completion
Mar 1, 2024 (estimated)
Last update
Aug 31, 2023

Study contacts

Josalyn L Cho, MD
principal investigator · University of Iowa

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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