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Completed NCT04901455

Responses to Live Attenuated Influenza Virus (LAIV) in Chronic Obstructive Pulmonary Disease (COPD)

Conditions: COPD

Sex: All
Ages: 40 Years – N/A
Healthy volunteers: Yes
Phase: EARLY_PHASE1
Enrollment: 24
Sponsor: University of North Carolina, Chapel Hill

Location: Eastowne Medical Office Building Chapel Hill North Carolina

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 Criteria

Inclusion Criteria: 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\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 Exclusion Criteria: * Inability or unwillingness to consent * Active tobacco or e-cigarette use (within last six months) * Active diagnosis of asthma * Any regular suppressive antibiotics (i.e., azithromycin) * Daily oral prednisone use * Any supplemental oxygen use beyond nocturnal oxygen therapy * Use of intranasal corticosteroids in the 30 days prior to screening visit * Chronic illness associated with immunosuppression (i.e., HIV, malignancy) * History of documented or self-reported positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection requiring hospitalization * Receipt of SARS-CoV-2 vaccine within 14 days prior to study screening visit or plan to receive SARS-CoV-2 vaccine from screening visit to 14 days after completion of all study procedures * History of epistaxis, prior nasal surgery or anatomical abnormalities * Current use of blood thinner beyond full dose aspirin \[e.g., warfarin (coumadin), clopidogrel (Plavix), dabigatran (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis)\] * Self-reported history of easy bruising or bleeding gums * Serological evidence of HIV infection at screening (Positive HIV antibody test) * Relative leukopenia (WBC\

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04901455). StuddyBuddy aggregates publicly available trial information.