Flu vaccine study aims to uncover why some COPD patients suffer more flare-ups

NCT ID NCT04901455

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

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

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for COPD are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.