Flu vaccine study aims to uncover why some COPD patients suffer more flare-ups
NCT ID NCT04901455
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked at how the nasal immune system of people with COPD reacts to a live flu vaccine (FluMist). Researchers compared those who have frequent COPD flare-ups to those who do not, to see if differences in immune response or viral replication might explain the flare-ups. The study involved 24 participants and measured immune markers and viral clearance over three days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Live attenuated influenza vaccine (LAIV, FluMist)
- What this could lead to
- If successful, this could help identify why some COPD patients have more frequent flare-ups and point toward better prevention strategies.
- What could go wrong
- This is a very early, small study (24 participants) focused on immune markers, not on treating or preventing COPD. Results may not lead to any direct benefit for patients.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
24 people
The number who actually took part.
- Started
-
Oct 2022
- Finished
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Feb 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
40 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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\<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 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\<4000), neutropenia (Absolute neutrophil count\<2000) or lymphopenia (absolute lymphocyte count\<1500) on screening CBC * Respiratory infection (cough, sore throat, sinusitis, fever) within prior 4 weeks * Active wheezing at day 0 visit * 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) * Use of chronic immunosuppression in the 30 days prior to screening visit * 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 * History of Guillain-Barre syndrome * Subjects who will be unable to avoid contact with immunocompromised individuals for 3 weeks after receiving LAIV vaccine * Receipt of the LAIV during the current or prior flu vaccine season * 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") * Any condition that, in the opinion of the study investigator, would compromise the subject's ability to participate in the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Eastowne Medical Office Building
Chapel Hill, North Carolina, 27514, United States
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