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Study of the Inflammation and Airway Changes That Occur After Exposure to Allergen in Asthmatics (ACE)

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ClinicalTrials.gov Identifier: NCT02230189
Recruitment Status : Recruiting
First Posted : September 3, 2014
Last Update Posted : July 19, 2017
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Prescott Woodruff, University of California, San Francisco

Brief Summary:
This protocol describes a single site mechanistic study to investigate microRNAs (miRNAs) that are differentially expressed in the airway epithelium of patients with asthma at baseline and in response to allergen challenge. We hypothesize that allergen exposure enhances airway smooth muscle contractility and epithelial cell mRNA/miRNA production as a consequence of locally increased T-cell derived cytokine production. The study will involve three visits over the course of approximately 14 days. At Visit 1, participants will be characterized in detail with lung function testing, methacholine challenge testing, and allergen skin prick testing. At Visit 2, participants will undergo bronchoscopy with segmental allergen administration of either cat or dust mite standardized allergen extract. At Visit 3 (either 24 hours later or 7 days later), bronchoscopy will be performed to collect airway samples including bronchoalveolar lavage (BAL), epithelial brushings and endobronchial biopsies. Sample analysis will include measurement of miRNA and mRNA expression in epithelial brushings (RNAseq and qPCR); analysis of cell surface markers on BAL cells and blood cells; and collection of endobronchial biopsies for immunostaining of immune cells localization, immunoblotting of smooth cell protein phosphorylation, analysis of mucin content and smooth muscle cell subculture. A total of 38 subjects (26 asthmatics with stable or well-controlled asthma, 6 allergic non-asthmatics and 6 non-allergic non-asthmatics) will complete the study.

Condition or disease Intervention/treatment Phase
Asthma Biological: Segmental airway allergen challenge Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Mechanistic Study of Epithelial miRNAs and T-cell Recruitment Dynamics That Occur After Allergen Challenge in Patients With Asthma.
Study Start Date : March 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Non-allergic/Non-asthmatic subjects
Intervention: Segmental airway allergen challenge Group: Volunteers with neither asthma nor allergy (as established by skin prick testing)
Biological: Segmental airway allergen challenge
Experimental: Allergic/Non-asthmatic subjects
Intervention: Segmental airway allergen challenge Group: Volunteers with allergy (as established by skin prick testing) but without asthma
Biological: Segmental airway allergen challenge
Experimental: Allergic/Asthmatic subjects
Intervention: Segmental airway allergen challenge Group: Volunteers with both asthma and allergy (as established by skin prick testing)
Biological: Segmental airway allergen challenge



Primary Outcome Measures :
  1. Difference in expression of epithelial miRNAs (in read counts) after allergen-challenge as compared to after diluent challenge [ Time Frame: 24 hours or 7 days ]
    After processing of the sequencing data to read counts, the difference in read count in the allergen challenged as compared to the diluent challenged segment at the given follow-up time point will be calculated for each subject. The change in read count for each miRNA in the allergen samples will be compared to the change in read count in the diluent samples and statistical significance will be assessed using the Benjamini Hochberg false discovery rate method (FDR) to account for multiple comparisons.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Allergic/Non-Asthmatic subjects and Allergic/Asthmatic subjects

Inclusion Criteria:

  • Positive skin test to dust mite or cat allergen

Non-Allergic/Non-Asthmatic subjects

Inclusion Criteria:

  • Negative skin test to panel of 12 allergens, including dust mite and cat allergen

All groups

Exclusion Criteria:

  • History of intubation for asthma exacerbation
  • Use of Xolair (omalizumab) within the last 6 months
  • Immunotherapy with cat or dust mite extract now or in the past 5 years
  • ≥ 10 pack-years smoking or any smoking in the past year
  • Other lung diseases, such as sarcoidosis, bronchiectasis or active lung infection
  • History of dermatographia
  • History of anaphylaxis to cat allergen
  • Participation in another research study involving a drug or biologic during the past 30 days
  • Presence of past or current medical problems/other factors that may pose additional risks from participation or influence study results, as determined per study investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02230189


Contacts
Contact: Bobby J Antalek, MS, MPH 415-502-2892 bobby.antalek@ucsf.edu
Contact: Christine P Nguyen, BS, CCRP 415-476-3824 christine.nguyen@ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Prescott G Woodruff, MD, MPH University of California, San Francisco

Additional Information:
Responsible Party: Prescott Woodruff, Professor of Medicine, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02230189     History of Changes
Other Study ID Numbers: 14-14224
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017

Keywords provided by Prescott Woodruff, University of California, San Francisco:
Asthma
Allergen challenge

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases