Last updated: 09/12/2025 10:00:07
RESP-DK: Real-world evidence study of AREXVY in adults with COPD in Denmark
GSK study ID
300432
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Will be recruiting
Will be recruiting
Trial overview
Official title: RESP-DK: Real-world evidence study of AREXVY in adults with COPD in Denmark
Trial description: The study estimates the uptake of AREXVY in Denmark among individuals aged ≥60 years with COPD and the effectiveness of AREXVY against Respiratory Syncytial Virus (RSV) hospitalization.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants who received AREXVY in Denmark among individuals aged ≥60 years with COPD following the provision of conditional reimbursement, among the total study cohort
Timeframe: From 5 August 2024 to 30 April 2025 (per calendar week and calendar month)
Secondary outcomes:
Number of participants who received AREXVY in Denmark among individuals aged ≥60 years with COPD following the provision of conditional reimbursement, among the total study cohort, by age, by region and comorbidity profile
Timeframe: From 5 August 2024 to 30 April 2025 (per calendar week and calendar month)
Comparison of baseline sociodemographic and clinical characteristics of individuals aged ≥60 years with COPD, among those who have been vaccinated with AREXVY and those that were not in the total study cohort
Timeframe: From 5 August 2024 to 30 April 2025
Effectiveness of AREXVY against RSV hospitalization, by comparing a vaccinated cohort with a matching eligible but not vaccinated cohort
Timeframe: From 5 August 2024 + 21 days to latest available data
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2025-30-09
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Respiratory Syncytial Virus Infections
Product
Not applicable
Collaborators
EY-Parthenon
Study date(s)
September 2025 to September 2025
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
60+ years
Accepts healthy volunteers
No
- Aged ≥60 years.
- Diagnosis of COPD.
- Individuals without a Danish personal identification number.
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosis of COPD. A diagnosis of COPD will be identified through registrations in the Danish National Patient Register (DNPR) and the National Prescription Register (LSR). Thus, a diagnosis of COPD will be determined based on meeting at least 1 of the criteria: 1. A hospital contact registered with J44 as the primary or secondary diagnosis code 2. At least 2 purchases of prescription medication (on 2 different days) registered in LSR and only approved for treatment of COPD Individuals eligible for inclusion will be assigned an index date 1 (i.e., inclusion index date) based on the latest occurrence of either inclusion criterion. Included individuals will subsequently be divided into vaccinated or unvaccinated groups, according to the below:
- Vaccinated. The group of vaccinated individuals comprises individuals who meet all the following criteria: o Receipt of the AREXVY vaccine during the inclusion period. o No receipt of any other RSV vaccination by the time of AREXVY vaccination.
- Unvaccinated. The group of unvaccinated individuals comprises individuals who meet all the following criteria: o No receipt of any RSV vaccination by index date 2 (i.e., vaccination index date). Unvaccinated individuals who subsequently receive RSV vaccination during the inclusion period will be eligible for the vaccinated group; vaccinated patients will not be eligible for the unvaccinated group after RSV vaccination date.
Aged ≥60 years.
Exclusion criteria:
Individuals without a Danish personal identification number.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Will be recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website