Responses to Live Attenuated Influenza Virus (LAIV) in Chronic Obstructive Pulmonary Disease (COPD) (NCT04901455) | Clinical Trial Compass
CompletedEarly Phase 1
Responses to Live Attenuated Influenza Virus (LAIV) in Chronic Obstructive Pulmonary Disease (COPD)
United States24 participantsStarted 2022-10-03
Plain-language 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 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 part…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used a live attenuated influenza vaccine in people with COPD — since it's a live virus, is there any concern that receiving LAIV could trigger a flare-up or exacerbation given my lung condition?
2The trial specifically compared 'frequent exacerbators' versus 'infrequent exacerbators' of COPD — based on my own exacerbation history, which group would I fall into, and does that affect what the results might mean for me?
3Since this was an early Phase 1 study that has already completed, what were the key safety findings, and is there any published data we can review together before I consider anything related to LAIV?
4Because this was a very early-phase study focused on measuring immune responses rather than proving a treatment benefit, does it change the recommendations for which type of flu vaccine — live attenuated or the standard inactivated shot — I should be getting right now?
5Are there follow-up studies building on these results that might be recruiting, or is the standard inactivated flu vaccine still the safer and better-supported choice for someone with my stage of COPD?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in mucosal immune response between COPD frequent exacerbators and COPD infrequent exacerbators