About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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]
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
RSV vaccination (Arexvy, GlaxoSmithKline)
Biological/VaccineA single dose of RSV vaccination (Arexvy, GlaxoSmithKline) at the start of study
Treatment groups
Trial outcomes
Primary outcomes
Number of all-cause moderate-to-severe AECOPD
Comparison of the number of all-cause moderate-to-severe AECOPD between the RSV and SOC groups over 1 year
Secondary outcomes
Number of all-cause severe AECOPD
Comparison of the number of all-cause AECOPD between the RSV and SOC groups over 1 year
Number of moderate-to-severe and severe AECOPD with RSV infection
Comparison of the number of moderate-to-severe AECOPD with RSV infection between the RSV and SOC groups over 1 year
Time to first all-cause moderate-to-severe and severe AECOPD
Comparison of the time to first all-cause moderate-to-severe AECOPD between the RSV and SOC groups over 1 year
Time to first moderate-to-severe and severe AECOPD with RSV infection
Comparison of the time to first moderate-to-severe AECOPD with RSV infection between the RSV and SOC groups over 1 year
Sponsors and contacts
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Chinese University of Hong Kong
Lead sponsor
The University of Hong Kong
Collaborator
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