RECRUITING

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

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Conditions

COPD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-10-03
Study Completion:2025-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04901455

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age\>40 years old
  2. * 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 at screening
  3. * Free of acute exacerbation of COPD for prior four weeks at time of recruitment
  4. * Resting oxygen saturation \>94 percent
  5. * Blood pressure systolic values between 90-160 mm Hg and diastolic between 55-90 mm Hg
  6. * No nasal symptoms based on questionnaire
  7. * Willingness and ability to participate in study procedures
  8. * Completion of informed consent
  9. * Age\>40 years old
  10. * Spirometry testing showing normal lung function (defined as pre and post--bronchodilator FEV1/FVC\>=lower limit of normal and FEV1\>80 percent predicted) at screening
  11. * Resting oxygen saturation \>94 percent
  12. * Blood pressure systolic values between 90-160 mm Hg and diastolic between 55-90 mm Hg
  13. * No nasal symptoms based on questionnaire
  14. * Willingness and ability to participate in study procedures
  15. * Completion of informed consent
  1. * Inability or unwillingness to consent
  2. * Active tobacco or e-cigarette use (within last six months)
  3. * Active diagnosis of asthma
  4. * Any regular suppressive antibiotics (i.e., azithromycin)
  5. * Daily oral prednisone use
  6. * Any supplemental oxygen use beyond nocturnal oxygen therapy
  7. * Use of intranasal corticosteroids in the 30 days prior to screening visit
  8. * Chronic illness associated with immunosuppression (i.e., HIV, malignancy)
  9. * History of documented or self-reported positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection requiring hospitalization
  10. * 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
  11. * History of epistaxis, prior nasal surgery or anatomical abnormalities
  12. * Current use of blood thinner beyond full dose aspirin \[e.g., warfarin (coumadin), clopidogrel (Plavix), dabigatran (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis)\]
  13. * Self-reported history of easy bruising or bleeding gums
  14. * Serological evidence of HIV infection at screening (Positive HIV antibody test)
  15. * Relative leukopenia (WBC\<4000), neutropenia (Absolute neutrophil count\<2000) or lymphopenia (absolute lymphocyte count\<1500) on screening CBC
  16. * Respiratory infection (cough, sore throat, sinusitis, fever) within prior 4 weeks
  17. * Active wheezing at day 0 visit
  18. * Pregnancy or nursing or women who are currently trying to become pregnant. (All female subjects, except those who have had a hysterectomy with oophorectomy, will undergo urine pregnancy testing on the morning of the screening visit and again on the on Day 0 at the time of arrival to the lab and prior to LAIV administration. A positive pregnancy test will exclude the subject)
  19. * Use of chronic immunosuppression in the 30 days prior to screening visit
  20. * History of hypersensitivity, especially anaphylactic reactions, to egg proteins, gentamicin, gelatin, or arginine, or with a reaction to previous influenza vaccination at a severity level precluding the subject's participation as judged by the study physician
  21. * History of Guillain-Barre syndrome
  22. * Subjects who will be unable to avoid contact with immunocompromised individuals for 3 weeks after receiving LAIV vaccine
  23. * Receipt of the LAIV during the current or prior flu vaccine season
  24. * Physician diagnosed influenza, a positive test for influenza or suspicion of influenza illness in the 18 months prior to enrollment. Suspicion of influenza will be based on the CDC's influenza-like illness case definition ("fever\>100 °F AND cough/sore throat in the absence of a known cause other than influenza. Temperature can be measured in the office or at the home")
  25. * Any condition that, in the opinion of the study investigator, would compromise the subject's ability to participate in the study

Contacts and Locations

Study Contact

Michael B Drummond, MD
CONTACT
984-974-2969
brad_drummond@med.unc.edu
Caleb Hemphill
CONTACT
984-974-2969
caleb_hemphill@med.unc.edu

Principal Investigator

Michael B Drummond, MD
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill

Study Locations (Sites)

Eastowne Medical Office Building
Chapel Hill, North Carolina, 27514
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • Michael B Drummond, MD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-03
Study Completion Date2025-03

Study Record Updates

Study Start Date2022-10-03
Study Completion Date2025-03

Terms related to this study

Additional Relevant MeSH Terms

  • COPD