Last updated: 11/09/2023 16:00:42
Real-world effectiveness of Fluticasone furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) versus (vs) multiple inhaler triple therapies
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Real-world comparative effectiveness of FF/UMEC/VI vs multiple inhaler triple therapies among patients with Chronic Obstructive Pulmonary Disease in the UK
Trial description: The aim of this study is to compare the effectiveness of a single inhaler FF/UMEC/VI (TRELEGY® ELLIPTA®) vs multiple inhaler triple therapies (MITT) on rates of exacerbations, healthcare resource use (HCRU) and associated direct medical costs among participants newly initiating triple therapy with chronic obstructive pulmonary disease (COPD) in England. TRELEGY ELLIPTA is a registered trademark of GlaxoSmithKline group of companies.
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Rate of moderate to severe acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in participants receiving single inhaler FF/UMEC/VI vs MITT
Timeframe: Up to 12 months post-index
Rate of moderate-to-severe AECOPDs in participants receiving single inhaler FF/UMEC/VI vs MITT with any prior therapy
Timeframe: Up to 12 months post-index
Secondary outcomes:
Rate of moderate AECOPD in participants receiving single inhaler FF/UMEC/VI vs MITT
Timeframe: Up to 12 months post-index
Rate of severe AECOPD in participants receiving single inhaler FF/UMEC/VI vs MITT
Timeframe: Up to 12 months post-index
Number of participants with all cause and COPD-related HCRU who initiated single inhaler FF/UMEC/VI vs MITT
Timeframe: Up to 12 months post-index
Number of participants with all cause and COPD-related direct medical cost who initiated single inhaler FF/UMEC/VI vs MITT
Timeframe: Up to 12 months post-index
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2022-25-11
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide
Collaborators
NA
Study date(s)
October 2021 to November 2022
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
35+ years
Accepts healthy volunteers
No
- Core 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 history prior to the index date.
Inclusion and exclusion criteria
Inclusion criteria:
- Core 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 history prior to the index date.
- Participants with most recent smoking status prior to index date (at any point in the participants medical history) of ‘current’ or ‘former’ smoker derived from all medical codes.
- Participants with record linked to the Hospital Episode Statistics (HES).
- Participants who were continuously registered with a general physician practice for a minimum of 365 days prior to the index date and a minimum of 180 days following the index date. Inclusion criteria for FF/UMEC/VI cohort:
- Participant with greater than or equal to (>=)1 prescription observable of single inhaler FF/UMEC/VI within the indexing period.
- Participant with no use of single inhaler FF/UMEC/VI prior to the indexing period. Additional criteria for all objectives excluding primary objective:2
- Participant with no MITT prescribed in the 12 months prior to index date. Additional criteria for primary objective 2 only
- Participant with no prescription of a maintenance therapy combination prior to index date that includes an FF as the Inhaled corticosteroid (ICS) component (mono, dual, or, triple therapy) Inclusion criteria for MITT cohort:
- Participant with MITT >=1 overlapping days of supply with all three triple therapy components within the indexing period. Additional criteria for all objectives excluding primary objective 2
- Participant with no use of MITT prior to the indexing period.
- Participant with no single inhaler FF/UMEC/VI prescribed in the 12 months prior to index date. Additional criteria for primary objective 2 only
- Participant with no use of an ELLIPTA device as part of a MITT regimen (REVLAR® ELLIPTA [FF/VI], ANORO® ELLIPTA [UMEC/VI], INCRUSE® ELLIPTA [UMEC], ARNUITY® ELLIPTA [FF]). (REVLAR, ANORO, INCRUSE and ARNUITY are registered trademarks of GlaxoSmithKline group of companies)
- Participant with index MITT ICS component(s) not contained within immediately prior therapy (mono, dual, or, triple therapy) Exclusion Criteria:
- Participant with at least one diagnostic code of any medical condition that is incompatible with a COPD diagnosis at any time in the participant 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.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Protocol
Available language(s): English
Statistical analysis plan
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
2022-25-11
Actual study completion date
2022-25-11
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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