COPDEarly Phase 1NCT04901455
Responses to Live Attenuated Influenza Virus (LAIV) in Chronic Obstructive Pulmonary Disease (COPD)
A Early Phase 1 study testing LAIV in people with COPD, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- LAIV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2022to 16 Feb 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastowne Medical Office Building
Chapel Hill, North Carolina, 27514
About this study
Official title: Nasal Mucosal Immune Responses to Live Attenuated Influenza Virus (LAIV) in Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Phenotypes
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.
Read the detailed description
This study is an early Phase 1, single-center, single-group unmasked exposure study of nasal immune responses after controlled exposure to LAIV. This trial will test the differences in the nasal immune responses to the nasal flu vaccine in two diseased groups of individuals along with healthy controls: 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 (defined as individuals with less than two episodes of worsening in COPD symptoms requiring treatment with antibiotics and/or steroids in the prior 12 months). A healthy control cohort will also be recruited, defined as individuals with spirometry-confirmed normal lung function and no asthma history. A total of 15 COPD frequent exacerbators, 15 infrequent exacerbators and 10 healthy controls will be enrolled for this trial. Investigators will balance the sex of participant as closely as possible to 50% male and 50% female.
At screening visit, after obtaining informed consent and authorization to obtain medical records, all potential individuals will be screened for specific inclusion and exclusion criteria to ensure suitability and safety to receive the influenza nasal vaccine. A baseline assessment will be done including reviewing medical history and verifying eligibility, a physical exam by a study investigator, spirometry testing before and after bronchodilator, laboratory testing to screen for immunocompromised state [Human Immunodeficiency Virus (HIV) antibody testing, compete blood count (CBC) with differential], an assessment of symptoms, and pregnancy testing if pre-menopausal. Women who are pregnant, nursing, or women who are currently trying to become pregnant are not eligible for this study.
Participants who meet eligibility after screening will be brought back for an enrollment visit where they will undergo a baseline assessment of their nasal inflammatory state. This includes sampling of the nose in three different ways. First, investigators will gently place a small strip of absorbent paper inside the lower part of the nose, and a nose clip will be applied for two minutes (ELF collection). Next, investigators will wash the inside of the nose with a small amount of sterile salt water to collect samples (NLF collection). Finally, investigators will take a small plastic device and gently scrape the inside of the nose to collect nasal cells (scraping collection). Investigators will also collect blood samples for inflammatory phenotyping.
Within two weeks of enrollment visit, all enrolled individuals will receive the nasal influenza vaccine (there is no placebo component to the study). On days one, two, three, and seven after vaccine administration, participants will return to the study site to undergo nasal sampling including the nasal paper strip and washing, as well as blood collection. On Day 3, a nasal scraping will also be obtained. On Day 21 (optional visit), investigators will obtain nasal washing and blood collection. Investigators will collect patient reported outcomes using a validated influenza severity score to assess for unbiased correlations with biological measures.
- Conditions
- COPD
- Being tested
- LAIV
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAIVBiological
Also called FluMist
Standard dose of LAIV administered by a licensed health care providers.
| Study group | Role | What they receive |
|---|---|---|
| COPD Frequent Exacerbators | Experimental | Individuals with two or more episodes of worsening in COPD symptoms requiring treatment with antibiotics and/or steroids in the prior 12 months Receives: Biological: LAIV |
| COPD Infrequent Exacerbators | Experimental | Individuals with less than two episodes of worsening in COPD symptoms requiring treatment with antibiotics and/or steroids in the prior 12 months Receives: Biological: LAIV |
| Healthy Control | Experimental | Individuals with spirometry-confirmed normal lung function and no asthma history Receives: Biological: LAIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mucosal immune response between COPD frequent exacerbators and COPD infrequent exacerbators
Epithelial lining fluid interferon-gamma (INF-ɣ) area under the curve (AUC) from day 0 (baseline) to day 3 (pg/mL x days)
Measured: Baseline, Day 3
Secondary outcomes (1)
Difference in viral clearance between COPD frequent exacerbators and COPD infrequent exacerbators
Nasal scrape influenza gene expression AUC from day 0 (baseline) to day 3
Measured: Baseline, Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start3 Oct 2022
- Primary completion16 Feb 2026
- Study completion16 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study is an early Phase 1, single-center, parallel-group unmasked exposure study of nasal immune responses after controlled exposure to LAIV.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Michael B Drummond, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901455
- Sponsor's protocol ID
- 21-0254
- Other IDs
- 1R01HL150081-01A1
- Status last verified
- Feb 2026
- First submitted
- 20 May 2021
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Mucosal Immune Responses to Live Attenuated Influenza Virus (LAIV) in Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Phenotypes
- ClinicalTrials.gov ID
- NCT04901455
- Acronym / sponsor ID
- 21-0254
- Conditions
- COPD
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 16 Feb 2026 (actual)
- Study completion
- 16 Feb 2026 (actual)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is an early Phase 1, single-center, single-group unmasked exposure study of nasal immune responses after controlled exposure to LAIV. This trial will test the differences in the nasal immune responses to the nasal flu vaccine in two diseased groups of individuals along with healthy controls: 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 (defined as individuals with less than two episodes of worsening in COPD symptoms requiring treatment with antibiotics and/or steroids in the prior 12 months). A healthy control cohort will also be recruited, defined as individuals with spirometry-confirmed normal lung function and no asthma history. A total of 15 COPD frequent exacerbators, 15 infrequent exacerbators and 10 healthy controls will be enrolled for this trial. Investigators will balance the sex of participant as closely as possible to 50% male and 50% female.
At screening visit, after obtaining informed consent and authorization to obtain medical records, all potential individuals will be screened for specific inclusion and exclusion criteria to ensure suitability and safety to receive the influenza nasal vaccine. A baseline assessment will be done including reviewing medical history and verifying eligibility, a physical exam by a study investigator, spirometry testing before and after bronchodilator, laboratory testing to screen for immunocompromised state [Human Immunodeficiency Virus (HIV) antibody testing, compete blood count (CBC) with differential], an assessment of symptoms, and pregnancy testing if pre-menopausal. Women who are pregnant, nursing, or women who are currently trying to become pregnant are not eligible for this study.
Participants who meet eligibility after screening will be brought back for an enrollment visit where they will undergo a baseline assessment of their nasal inflammatory state. This includes sampling of the nose in three different ways. First, investigators will gently place a small strip of absorbent paper inside the lower part of the nose, and a nose clip will be applied for two minutes (ELF collection). Next, investigators will wash the inside of the nose with a small amount of sterile salt water to collect samples (NLF collection). Finally, investigators will take a small plastic device and gently scrape the inside of the nose to collect nasal cells (scraping collection). Investigators will also collect blood samples for inflammatory phenotyping.
Within two weeks of enrollment visit, all enrolled individuals will receive the nasal influenza vaccine (there is no placebo component to the study). On days one, two, three, and seven after vaccine administration, participants will return to the study site to undergo nasal sampling including the nasal paper strip and washing, as well as blood collection. On Day 3, a nasal scraping will also be obtained. On Day 21 (optional visit), investigators will obtain nasal washing and blood collection. Investigators will collect patient reported outcomes using a validated influenza severity score to assess for unbiased correlations with biological measures.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study is an early Phase 1, single-center, parallel-group unmasked exposure study of nasal immune responses after controlled exposure to LAIV.
| Arm | Type | Receives |
|---|---|---|
| COPD Frequent Exacerbators | Experimental | Biological: LAIVIndividuals with two or more episodes of worsening in COPD symptoms requiring treatment with antibiotics and/or steroids in the prior 12 months |
| COPD Infrequent Exacerbators | Experimental | Biological: LAIVIndividuals with less than two episodes of worsening in COPD symptoms requiring treatment with antibiotics and/or steroids in the prior 12 months |
| Healthy Control | Experimental | Biological: LAIVIndividuals with spirometry-confirmed normal lung function and no asthma history |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAIVAlso: FluMistStandard dose of LAIV administered by a licensed health care providers. | Biological | COPD Frequent Exacerbators, COPD Infrequent Exacerbators, Healthy Control |
Primary outcome
Difference in mucosal immune response between COPD frequent exacerbators and COPD infrequent exacerbators
Time frame: Baseline, Day 3
Epithelial lining fluid interferon-gamma (INF-ɣ) area under the curve (AUC) from day 0 (baseline) to day 3 (pg/mL x days)
1 secondary outcome
Difference in viral clearance between COPD frequent exacerbators and COPD infrequent exacerbators
Time frame: Baseline, Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael B Drummond, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing LAIV in people with COPD, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mucosal immune response between COPD frequent exacerbators and COPD infrequent exacerbators (time frame: Baseline, Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.