AzTrials
AzTrials

Allergic AsthmaPhase 1NCT04619017

Airway Immune Response to Allergens (Use Lay Language Here)

A Phase 1 study testing Segmental allergen challenge in people with Allergic Asthma and Allergy to Cats, run by JOSALYN CHO at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 to 50 years
What is being tested?
Segmental allergen challenge
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesUnited States
Study dates
28 Oct 2021to 1 Mar 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Individuals who meet all of the following criteria are eligible for enrollment as study participants:
  • Participant must be able to understand and provide informed consent.
  • Age between 18 and 50 years.
  • Clinical history of at least one of the following reactions to cat dander or dust mite:
  • Allergic rhinitis, with one or more of nasal congestion, sneezing, runny nose or post- nasal drainage,
  • Allergic conjunctivitis, with one or more of ocular itching, tearing or swelling, or
Show all 22Show fewer
  • Urticarial reactions to contact with cats.
  • 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.
  • Negative urine pregnancy test at all visits for female participants of reproductive potential.
  • Female participants with reproductive potential must agree to use an FDA approved method of birth control 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.
  • Life-long absence of cigarette smoking, defined as a lifetime total of less than 10 pack-years and none in the past year.
  • 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:
  • Clinical history of asthma.
  • 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).
  • 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.
  • In addition to inclusion criteria 1 - 8 above, allergic non-asthmatic control participants must meet all of the following criteria:
  • Baseline FEV1 no less than 90% of the predicted value.
  • Methacholine PC20 ≥ 16 mg/ml.

Who cannot join

  • Individuals who meet any of these criteria are not eligible for enrollment as study participants:
  • Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
  • 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.
  • Other lung diseases, including but not limited to sarcoidosis, bronchiectasis and active lung infection.
  • History of a respiratory tract infection within 6 weeks of Study Visits #1 and #2.
  • 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.
Show all 30Show fewer
  • Participant reported history of coagulopathy, thrombocytopenia or pulmonary hypertension.
  • Intolerance to albuterol, atropine, lidocaine, fentanyl, or midazolam.
  • Laboratory values within 12 weeks prior to Study Visits #1 and #2 that demonstrate:
  • Platelet count less than 80,000/mm3,
  • Prothrombin time (PT) more than 1.5 x upper limit of normal (ULN), or
  • Partial thromboplastin time (PTT) more than 1.5 x ULN.
  • Females of reproductive potential who are documented to be pregnant (based on urine beta-human chorionic gonadotropin (b-HCG) testing), are sexually active and not using contraception, are seeking to become pregnant, or who are breast feeding.
  • Current or former use of targeted biological therapy for asthma or allergic disorders including but not limited to benralizumab, dupilumab, mepolizumab, omalizumab, and reslizumab.
  • Current or past immunotherapy with cat or dust mite extract.
  • Antibiotic use within 6 weeks of Study Visits #1 and #2.
  • Use of systemic steroids within 4 weeks of any Screening or Study Visit. Participants may be rescreened after completion of steroid treatment.
  • Current use of beta blockers and monoamine oxidase (MAO) inhibitors.
  • Current use of anti-coagulants including but not limited to apixaban, clopidogrel, dabigatran, dalteparin, danaparoid, enoxaparin, heparin, rivaroxaban, tinzaparin, and warfarin.
  • Use of aspirin or NSAIDs and inability to stop these medications for 7 days prior to Study Visits #1 and #2.
  • Non-English speakers.
  • 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.
  • Use of investigational drugs within 30 days of participation.
  • 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:
  • 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.
  • Increased use of inhaled corticosteroids within 4 weeks of Screening Visit #1.
  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02214

  • University of Iowa

    Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: Airway Dendritic Cells in the Allergic Asthma Phenotype

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.

Being tested
Segmental allergen challenge
Keywords
asthma, allergy, allergic rhinitis, allergic conjunctivitis, cat allergy, house dust mite allergy
Medical subject headings
Dust Mite Allergy, Rhinitis, Allergic, Conjunctivitis, Allergic, Asthma, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Segmental allergen challengeBiological

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

Study groups in NCT04619017
Study groupRoleWhat they receive
Segmental allergen challengeExperimentalAllergic individuals with and without asthma will be enrolled.
Receives: Biological: Segmental allergen challenge

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dendritic cell number and phenotype

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

    Measured: 18 months

  2. Dendritic cell function

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

    Measured: 18 months

  3. Immune composition of the airway

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

    Measured: 18 months

  4. Mediators of organized airway immune tissue formation

    Mediator levels in lung washes

    Measured: 18 months

  5. Organized airway immune tissue

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

    Measured: 18 months

Secondary outcomes (3)

  1. Antibodies in lung washes

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

    Measured: 18 months

  2. Antibodies in blood

    Quantification of IgE and IgG in blood

    Measured: 18 months

  3. Cytokines

    Quantification of type 2 cytokines in lung washes

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2020
  2. Study start28 Oct 2021
  3. Primary completion8 Apr 2023
  4. Study completion1 Mar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
This is a single-center, open-label, single-arm, controlled mechanistic study. All participants will receive an investigational product.
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04619017
Sponsor's protocol ID
Placeholder
Status last verified
Aug 2023
First submitted
26 Oct 2020
Last updated
31 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Segmental allergen challenge in people with Allergic Asthma and Allergy to Cats, run by JOSALYN CHO at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dendritic cell number and phenotype (time frame: 18 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04619017.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in