Last updated: 04/22/2026 13:40:23
RESP-DK: Real-world Evidence Study of AREXVY in Adults with COPD in Denmark: a Two-year Analysis
GSK study ID
305589
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Planned
Planned
Trial overview
Official title: RESP-DK: Real-world evidence study of AREXVY in adults with COPD in Denmark: a two-year analysis
Trial description: This study is designed to evaluate the effectiveness of AREXVY in preventing Respiratory Syncytial Virus (RSV) hospitalization and other outcomes across two consecutive RSV seasons in a population of adults aged 60 years and older with Chronic Obstructive Pulmonary Disease (COPD). The purpose of the real-world effectiveness estimates is to complement clinical trial data and support evidence-based decision making regarding RSV prevention strategies in this high risk group.
Primary purpose:
Prevention
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
1-season effectiveness of one dose of AREXVY (compared with no RSV vaccination) against RSV-coded hospitalization (narrower definition)
Timeframe: From 05 August 2024 to 31 May 2026
Secondary outcomes:
1-season effectiveness of one dose of AREXVY (compared with no RSV vaccination) against RSV-coded hospitalization (narrower definition), stratified by season (RSV seasons 2024/25 and 2025/26)
Timeframe: From 05 August 2024 to 31 May 2026
2-season effectiveness of one dose of AREXVY (compared with no RSV vaccination) against RSV-coded hospitalization (narrower definition), for individuals vaccinated in the first season (i.e., RSV season 2024/25)
Timeframe: From 05 August 2024 to 31 May 2026
1-season and 2-season effectiveness of one dose of AREXVY against RSV-coded hospitalization or ARI-coded hospitalization with an RSV positive laboratorial test (intermediate definition)
Timeframe: From 05 August 2024 to 31 May 2026
1-season and 2-season effectiveness of 1 dose of AREXVY against RSV-coded hospitalization or ARI-coded hospitalization with RSV positive laboratorial test or COPD exacerbation coded hospitalization with RSV positive laboratorial test (broader definition)
Timeframe: From 05 August 2024 to 31 May 2026
1-season and two-season effectiveness of one dose of AREXVY against RSV-positive laboratorial test
Timeframe: From 05 August 2024 to 31 May 2026
Number and proportion of AREXVY vaccination in Denmark, per season and per calendar month, overall and in subgroups based on age, region, and comorbidity profile
Timeframe: From 05 August 2024 to 31 May 2026
Baseline sociodemographic and clinical characteristics of individuals vaccinated with AREXVY compared with unvaccinated individuals, overall and stratified by season
Timeframe: From 05 August 2024 to 31 May 2026
Interventions:
Not applicable
Enrollment:
11000
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Respiratory Syncytial Virus Infections
Product
Not applicable
Collaborators
Not applicable
Study date(s)
May 2026 to July 2026
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
60+ years
Accepts healthy volunteers
No
- 1. Having a Danish Civil Registration System (CPR) number.
- 2. Aged >=60 years on 5th August 2024 or during the inclusion period.
- 1. Individuals with registration of RSV vaccination in the Prescription Register but not in The Vaccination Register (DDV) (i.e., incongruent information on vaccination status).
Inclusion and exclusion criteria
Inclusion criteria:
- 1. Having a Danish Civil Registration System (CPR) number. 2. Aged >=60 years on 5th August 2024 or during the inclusion period.
- Individuals must be >=60 years when the index date is assigned. 3. 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 following criteria: a. A hospital contact registered with J44 as the primary or secondary diagnosis code. b. At least 2 purchases of prescription medication (on 2 different days) registered in LSR and commonly used for treatment of COPD [Anatomical Therapeutic Chemical (ATC) codes]: R03AC18, R03AC19, R03AL02, R03AL03, R03AL04, R03AL05, R03AL06, R03AL07, R03AL08, R03AL11, R03BB05, R03BB06, R03BB07.
Exclusion criteria:
- 1. Individuals with registration of RSV vaccination in the Prescription Register but not in The Vaccination Register (DDV) (i.e., incongruent information on vaccination status).
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Planned
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
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