Immune Interactions in Severe Asthma

NCT02566668 | Completed

• 1 other identifier: PRO15050456
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is being done to learn more about severe asthma by comparing people with severe asthma to those with milder forms of asthma and people without asthma, at baseline and over time. Individuals are being asked to join a research study to help understand the differences in the lungs and blood of participants with severe asthma compared to those with milder asthma and healthy individuals, as well as differences in overall health. Investigators also want to determine whether these differences predict asthma-related and biologic outcomes over 1 year of follow up.

Conditions

Asthma

Keywords

Asthma; Severe Asthma; IL-10; IL-27; IL-13; Epithelial Cells; T lymphocytes; Interferon-g

Outcome Measures

Primary Outcomes (1)

• Eotaxin-3 and IL-27 expression and their downstream signatures

  Measure eotaxin-3 and IL-27 expression in bronchoalveolar lavage cells and epithelial cells.

  1 Year

Secondary Outcomes (3)

• Global gene expression in the airway epithelium and bronchoalveolar lavage cells using RNA-sequencing

  1 Year

• Signal transducer and activator of transcription (STAT) signaling pathways

  1 Year

• Targeted and untargeted gene expression as obtained from bronchoscopic samples

  1 Year

Study Arms (2)

Asthmatic

1 year observational follow-up

Other: 1 year Observational Follow-up

Non-Asthmatic

1 year observational follow-up

Other: 1 year Observational Follow-up

Interventions

1 year Observational Follow-up OTHER

Approximately 12 months after research bronchoscopy, subjects will return for follow-up visit.

Asthmatic; Non-Asthmatic

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be selected using a Research Registry and clinic patients of the Investigators.

You may qualify if:

• years of age
• Non-smoker
• Asthmatic subjects must also demonstrate forced expiratory volume in 1 second (FEV1) bronchodilator reversibility ≥12% or airway hyperresponsiveness reflected by a methacholine provocative concentration causing a 20% fall in FEV1 (PC20) ≤16 mg/mL (Historical methacholine data from previous National Institutes of Health (NIH) trial will be allowed)

You may not qualify if:

• Greater than 10 pack year smoking history (none in the last year)
• Vocal cord dysfunction, cystic fibrosis or chronic obstructive pulmonary disorder
• Other lung disease, or any coronary artery disease, hypertension, diabetes or renal failure that is not well-controlled.
• Healthy Controls only: Pre-bronchodilator FEV1/Forced vital capacity (FVC) \<0.70 or an improvement in FEV1 of more than 12% following 4 puffs of albuterol.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Asthma Institute at UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood - total and specific Immunoglobulin E (IgE); complete blood count; plasma and serum; Deoxyribonucleic Acid (DNA); peripheral blood mononuclear cells (PBMC) Endobronchial biopsy Endobronchial brushings Pulmonary Lavage Exhaled Breath Condensate (EBC)

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Sally E Wenzel, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: October 2, 2015
• Study Start: September 1, 2015
• Primary Completion: September 22, 2022
• Study Completion: August 22, 2024
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

US (1)