Nasal Mucosal Immune Responses to Live Attenuated Influenza Virus (LAIV) in Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Phenotypes

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

This study will determine the functional status of the nasal immune environment with LAIV exposure in COPD persons with frequent exacerbations (defined as individuals with two or more episodes of worsening in COPD symptoms requiring treatment with antibiotics and/or steroids in the prior 12 months) and COPD persons without frequent exacerbations to determine acute exacerbation of COPD (AECOPD)-associated dysfunction in a) cytokines and immune effector cells of the nasal mucosa and b) viral replication. The investigators hypothesize that: 1) COPD frequent exacerbators, compared to COPD infrequent exacerbators, will demonstrate altered mucosal immune responses to LAIV exposure, and 2) COPD frequent exacerbators, compared to COPD infrequent exacerbators, will demonstrate increased markers of influenza viral replication after LAIV exposure.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: t
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⁃ In order to be eligible to participate in this study, an individual in the COPD group must meet all of the following criteria:

• Age\>40 years old

• Physician diagnosis of COPD confirmed by post-bronchodilator testing (defined as forced expiratory volume in one second (FEV1)/forced vital capacity (FVC)\< lower limit of normal and FEV1/FVC\<0.70) and FEV1\>30% predicted based on spirometry testing available in the prior year or completed at screening (if no historical testing available)

• Free of acute exacerbation of COPD for prior four weeks at time of recruitment

• Resting oxygen saturation \>94 percent

• Blood pressure systolic values between 90-160 mm Hg and diastolic between 55-90 mm Hg

• No nasal symptoms based on questionnaire

• Willingness and ability to participate in study procedures

• Completion of informed consent

⁃ In order to be eligible to participate in this study, an individual in the healthy control group must meet all of the following criteria:

• Age\>40 years old

• Spirometry testing showing normal lung function (defined as pre and post--bronchodilator FEV1/FVC\>=lower limit of normal and FEV1\>80 percent predicted) based on spirometry testing available in the prior year or completed at screening (if no historical testing available)

• Resting oxygen saturation \>94 percent

• Blood pressure systolic values between 90-160 mm Hg and diastolic between 55-90 mm Hg

• No nasal symptoms based on questionnaire

• Willingness and ability to participate in study procedures

• Completion of informed consent

Locations
United States
North Carolina
Eastowne Medical Office Building
RECRUITING
Chapel Hill
Contact Information
Primary
Michael B Drummond, MD
brad_drummond@med.unc.edu
984-974-2969
Backup
Caleb Hemphill
caleb_hemphill@med.unc.edu
984-974-2969
Time Frame
Start Date: 2022-10-03
Estimated Completion Date: 2026-03
Participants
Target number of participants: 40
Treatments
Experimental: COPD Frequent Exacerbators
Individuals with two or more episodes of worsening in COPD symptoms requiring treatment with antibiotics and/or steroids in the prior 12 months
Experimental: COPD Infrequent Exacerbators
Individuals with less than two episodes of worsening in COPD symptoms requiring treatment with antibiotics and/or steroids in the prior 12 months
Experimental: Healthy Control
Individuals with spirometry-confirmed normal lung function and no asthma history
Sponsors
Leads: University of North Carolina, Chapel Hill
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov