Airway Immune Response to Allergens (Use Lay Language Here)

NCT04619017 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: Placeholder
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Dendritic cell number and phenotype

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

  18 months

• Dendritic cell function

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

  18 months

• Immune composition of the airway

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

  18 months

• Mediators of organized airway immune tissue formation

  Mediator levels in lung washes

  18 months

• Organized airway immune tissue

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

  18 months

Secondary Outcomes (3)

• Antibodies in lung washes

  18 months

• Antibodies in blood

  18 months

• Cytokines

  18 months

Study Arms (1)

Segmental allergen challenge

EXPERIMENTAL

Allergic individuals with and without asthma will be enrolled.

Biological: Segmental allergen challenge

Interventions

Segmental allergen challenge BIOLOGICAL

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

Segmental allergen challenge

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• JOSALYN CHO: lead
• Massachusetts General Hospital: collaborator

Study Sites (2)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

MeSH Terms

Conditions

Dust Mite Allergy; Rhinitis, Allergic; Conjunctivitis, Allergic; Asthma; Hypersensitivity

Condition Hierarchy (Ancestors)

Rhinitis, Allergic, Perennial; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Josalyn L Cho, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a single-center, open-label, single-arm, controlled mechanistic study. All participants will receive an investigational product.

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 6, 2020
• Study Start: October 28, 2021
• Primary Completion: April 8, 2023
• Study Completion: March 1, 2024
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)