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Virus Therapy
Nasal Flu Vaccine for COPD
Phase < 1
Recruiting
Led By Michael B Drummond, MD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Individual in the healthy control group must have no nasal symptoms based on questionnaire
Individual in the COPD group must have physician diagnosis of COPD confirmed by post-bronchodilator testing
Must not have
History of documented or self-reported positive SARS-CoV-2 infection requiring hospitalization
Respiratory infection within prior 4 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 3
Awards & highlights
No Placebo-Only Group
Summary
This trial will study how people with and without COPD respond to the influenza vaccine when given through the nose.
Who is the study for?
This trial is for adults over 40 with COPD, who've had two or more flare-ups in the past year requiring treatment. They must have stable blood pressure and oxygen levels, no recent tobacco use, and not be on certain medications like nasal steroids or immunosuppressants. People with asthma, recent respiratory infections, or those who can't avoid contact with immunocompromised individuals after vaccination are excluded.
What is being tested?
The study tests how a live attenuated influenza vaccine (LAIV) affects the nasal immune response in people with COPD. It compares those who frequently have exacerbations to those who don't by measuring cytokines, immune cells in the nose, and viral replication markers following LAIV exposure.
What are the potential side effects?
Potential side effects of LAIV may include a runny nose, sore throat, coughing, wheezing or worsening of existing lung conditions. There's also a risk of mild flu-like symptoms such as feverishness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have any nasal symptoms according to a questionnaire.
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I have been diagnosed with COPD, confirmed by a specific breathing test.
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I am over 40 years old and considered healthy.
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My blood pressure is between 90/55 and 160/90 mm Hg.
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I am over 40 years old and have COPD.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I was hospitalized due to COVID-19.
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I have not had a respiratory infection in the last 4 weeks.
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I am experiencing wheezing at the time of my visit.
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I often have easy bruising or my gums bleed.
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I have had nosebleeds, nasal surgery, or unusual nose shapes.
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I have been diagnosed with asthma.
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I am on regular antibiotics to prevent infections.
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I have had Guillain-Barre syndrome in the past.
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I take prednisone pills every day.
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I use oxygen therapy more than just at night.
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I have received the nasal spray flu vaccine this or last flu season.
Select...
I am currently taking a blood thinner that is not just aspirin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, day 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 3
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Difference in mucosal immune response between COPD frequent exacerbators and COPD infrequent exacerbators
Secondary study objectives
Difference in viral clearance between COPD frequent exacerbators and COPD infrequent exacerbators
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Healthy ControlExperimental Treatment1 Intervention
Individuals with spirometry-confirmed normal lung function and no asthma history
Group II: COPD Infrequent ExacerbatorsExperimental Treatment1 Intervention
Individuals with less than two episodes of worsening in COPD symptoms requiring treatment with antibiotics and/or steroids in the prior 12 months
Group III: COPD Frequent ExacerbatorsExperimental Treatment1 Intervention
Individuals with two or more episodes of worsening in COPD symptoms requiring treatment with antibiotics and/or steroids in the prior 12 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LAIV
2012
Completed Phase 4
~240
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,554 Previous Clinical Trials
4,293,088 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,928 Previous Clinical Trials
47,765,133 Total Patients Enrolled
Michael B Drummond, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
4 Previous Clinical Trials
169 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was hospitalized due to COVID-19.If you are in the healthy control group, your blood pressure should be between 90/55 and 160/90.I do not have any nasal symptoms according to a questionnaire.You have had severe allergic reactions to certain things in the past.I have not used any chronic immunosuppression medication in the last 30 days.I am willing and able to follow the study's procedures for COPD.I have not had a respiratory infection in the last 4 weeks.I am experiencing wheezing at the time of my visit.You have smoked cigarettes or used e-cigarettes in the last six months.I often have easy bruising or my gums bleed.I have had nosebleeds, nasal surgery, or unusual nose shapes.I have been diagnosed with asthma.I have used nasal sprays for allergies within the last month.I have been diagnosed with COPD, confirmed by a specific breathing test.I am on regular antibiotics to prevent infections.I have not had the COVID-19 vaccine within 14 days before or plan to until 14 days after the study.I am over 40 years old and considered healthy.I have had Guillain-Barre syndrome in the past.You have a positive result for HIV in your blood test.I take prednisone pills every day.You cannot stay away from people with weakened immune systems for 3 weeks after getting the LAIV vaccine.I use oxygen therapy more than just at night.You have a long-term illness that weakens your immune system.My blood pressure is between 90/55 and 160/90 mm Hg.I was diagnosed with or suspected to have had the flu in the last 18 months.I have received the nasal spray flu vaccine this or last flu season.I am over 40 years old and have COPD.I have COPD and no nasal symptoms according to a questionnaire.I am currently taking a blood thinner that is not just aspirin.People with COPD must have oxygen levels above 94% while at rest.If you are in the healthy control group, your oxygen level while resting should be more than 94 percent.Your blood test shows low levels of white blood cells, neutrophils, or lymphocytes.I haven't had a severe COPD flare-up in the last four weeks.People in the healthy control group must have normal lung function when tested with spirometry.
Research Study Groups:
This trial has the following groups:- Group 1: COPD Frequent Exacerbators
- Group 2: COPD Infrequent Exacerbators
- Group 3: Healthy Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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