Last updated: 01/02/2024 14:30:56
Prompt versus Delay use of TRELEGY® for COPD
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Prompt vs Delay use of Trelegy for COPD in the UK
Trial description: This observational study aims to assess whether prompt versus delayed initiation of Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) following a moderate or severe Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is associated with a difference in subsequent AECOPDs, hospital readmissions and Healthcare resource use (HCRU)/costs among participants with Chronic obstructive pulmonary disease (COPD) in England. TRELEGY is a registered trademark of GlaxoSmithKline (GSK) group of companies.
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Rate of AECOPDs (overall, moderate and severe episodes) in participants with no prior AECOPDs
Timeframe: Up to 2 years and 4 months
Secondary outcomes:
Time-to-first subsequent AECOPD (overall, moderate and severe episodes)
Timeframe: Up to 2 years and 4 months
All-cause and COPD-related hospital readmission
Timeframe: Up to 30, 60 and 90 days
Time-to-first hospital readmission
Timeframe: Up to 30, 60 and 90 days
All-cause and COPD-related HCRU and direct medical costs
Timeframe: Up to 2 years and 4 months
Rate of subsequent AECOPDs (overall, moderate and severe episodes) in participants with no prior triple therapy
Timeframe: Up to 2 years and 4 months
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2022-17-01
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Banks V, Camidge L, Compton C, Czira A, Halpin D, Ismaila A, et al. . Benefit of prompt initiation of single-inhaler fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI) in patients with COPD in England following an exacerbation - a retrospective cohort study. Respir Res.
DOI : 10.1186/s12931-023-02523-1
PMID : 37749551
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
Not applicable
Collaborators
Not applicable
Study date(s)
October 2021 to January 2022
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
35+ years
Accepts healthy volunteers
No
- Inclusion criteria:
- Participants with at least one diagnosis of COPD at age 35 years or above (to align with National Institute for Health and Care Excellence [NICE] guidance on COPD diagnosis and management) in Clinical Practice Research Datalink (CPRD) Aurum, that is (i.e.) primary care, at any time in the participant’s medical history, according to the relevant Read 2, Systematized Nomenclature of Medicine – Clinical Terms (SNOMED-CT) and local EMIS® codes.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria:
- Participants with at least one diagnosis of COPD at age 35 years or above (to align with National Institute for Health and Care Excellence [NICE] guidance on COPD diagnosis and management) in Clinical Practice Research Datalink (CPRD) Aurum, that is (i.e.) primary care, at any time in the participant’s medical history, according to the relevant Read 2, Systematized Nomenclature of Medicine – Clinical Terms (SNOMED-CT) and local EMIS® codes.
- At least one moderate or severe AECOPD on or after 15-Nov-2017. The date of the first / earliest AECOPD event (date of consultation for moderate AECOPDs, date of discharge for severe AECOPDs) will be defined as the index date.
- At least one prescription for FF/UMEC/VI on or within 180 days of the index date.
- A forced expiratory volume in one second (FEV1) / forced vital capacity (FVC) less than (<)0.7 at any time in the participant’s medical history prior to the index date.
- Record linked to the Hospital Episode Statistics (HES).
- Continuously registered with a General practitioner (GP) practice for a minimum of 12 months prior to the index date and a minimum of 12 months following and including the index date. Exclusion criteria:
- One or more AECOPD (moderate or severe) during the Baseline period.
- One or more prescription for Single inhaler triple therapy (SITT) (FF/UMEC/VI or Beclomethasone dipropionate/Formoterol fumarate/Glycopyrronium bromide [BDP/FF/GB]) prior to the index date.
- One or more prescription for other triple therapy products (i.e. Multiple inhaler triple therapy [MITT] or SITT BDP/FF/GB) between the index date and FF/UMEC/VI initiation.
- One or more diagnostic code of any medical conditions incompatible with a COPD diagnosis at any time in the participant’s medical history, i.e. conditions that are related to lung or bronchial developmental anomalies, degenerative processes (cystic fibrosis, pulmonary fibrosis), pulmonary resection or other significant respiratory disorders other than COPD that can interfere with clinical COPD diagnosis or substantially change the natural history of the disease prior to the index date.
- One or more prescription for MITT in the 12 months prior to the index date.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2022-17-01
Actual study completion date
2022-17-01
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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