Objectives: To determine whether respiratory syncytial virus (RSV) vaccination reduces the rate of all-cause moderate-to-severe acute exacerbations of COPD (AECOPD) in high-risk patients, and to characterise RSV-specific infection and immune responses in this population.
Hypothesis: RSV vaccination in COPD frequent exacerbators receiving dual long-acting bronchodilators will reduce all-cause moderate-to-severe AECOPD by at least 20-25% over 12 months.
Design and subjects: This multicentre, two-arm, open-label, prospective study will recruit 320 COPD patients with 2 moderate or severe AECOPD in the prior year despite dual long-acting bronchodilator therapy. Eligible subjects will be allocated 1:1 to receive RSV vaccination plus standard care or standard care alone and followed for 12 months.
Interventions: Participants in the vaccine arm will receive a single dose of a licensed RSV vaccine in addition to usual COPD management. Controls will receive usual care without RSV vaccination during the study period.
Main outcome measures: The primary outcome is the rate of all-cause moderate-to-severe AECOPD per patient-year. Secondary outcomes include RSV-positive AECOPD, RSV infection incidence confirmed by virological testing, severe AECOPD requiring hospitalisation, time to first moderate-to-severe AECOPD, and changes in plasma RSV-specific antibody titres over 12 months.
Data analysis and expected results: Exacerbation rates will be compared between groups using negative binomial regression with adjustment for key covariates on an intention-to-treat basis. The investigators expect RSV vaccination to achieve a clinically meaningful (20%) reduction in all-cause moderate-to-severe AECOPD and to provide mechanistic insights linking RSV immunity, RSV infection, and exacerbation risk in COPD frequent exacerbators.
Who can participate
Age range
50 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:
* Age 50 years or older
* Spirometry evidence of airflow obstruction (post-bronchodilator FEV1/FVC \<0.70)
* Current or former smoker who had accrued a ≥10 pack-year smoking history
* Frequent COPD exacerbator, as defined by at least ≥2 moderate or ≥1 severe AECOPD in the 12 months prior to screening \[31,32\]
* On dual LABD (LABA and LAMA) using the same inhaler/device for ≥8 weeks
* Up-to-date influenza and pneumococcal vaccination received at least 1 month prior to screening
Exclusion Criteria:
* Coexisting significant pulmonary disease predominating the respiratory symptoms (e.g. asthma, bronchiectasis)
* Life expectancy shorter than 1 year due to serious or unstable chronic illness (e.g. advanced lung cancer)
* Refused to receive RSV vaccine (for the RSV group only)
* Received RSV vaccine of any brand before
* Immunocompromised or long-term steroid user (≥10mg/day prednisolone or equivalent for ≥2 weeks), which may affect the RSV vaccine efficacy
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
* Pregnant or lactating (females not yet menopausal must have a negative pregnancy test before receiving the RSV vaccination)
* Unable to provide informed consent
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.