Last updated: 07/05/2024 13:10:12

Study to assess effectiveness outcomes in participants with COPD switching from multiple to single inhaler triple therapy in a real-world United Kingdom (UK) population

GSK study ID
218242
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An assessment of effectiveness outcomes in patients with Chronic Obstructive Pulmonary Disease switching from multiple to single inhaler triple therapy in a real-world UK population
Trial description: This study aims to compare the effectiveness of switching from Multiple inhaler triple therapy (MITT) to single inhaler Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) (TRELEGY ELLIPTA®) by evaluating rates of Acute exacerbation of chronic obstructive pulmonary diseases (AECOPDs), Healthcare resource use (HCRU) and associated direct medical costs among participants with Chronic obstructive pulmonary disease (COPD) in England. TRELEGY ELLIPTA 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:

Percentage of participants with one or more (moderate, severe and moderate-to-severe) AECOPD following switch from MITT to single inhaler FF/UMEC/VI

Timeframe: From 6 months pre-index to 6 months after index

Rate of (moderate, severe and moderate-to-severe) AECOPD following switch from MITT to single inhaler FF/UMEC/VI

Timeframe: Up to 12 months pre-index and up to 12 months after index

Secondary outcomes:

Rate of (moderate, severe and moderate-to-severe) AECOPD following switch from MITT to single inhaler FF/UMEC/VI in participants with one or more prior AECOPD whilst on MITT

Timeframe: Up to 12 months pre-index and up to 12 months after index

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2022-25-05
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Kieran J Rothnie, Robert P Wood, Alexandrosz Czira, Victoria L Banks, Lucinda J Camidge, Olivia K I Massey, Monica Seif, Chris Compton, Raj Sharma, David M G Halpin, Afisi S Ismaila, Claus F Vogelmeier. Outcomes of patients with COPD switching from multiple-inhaler to once-daily single-inhaler triple therapy in a real-world primary care setting in England: a retrospective pre-post cohort study.. BMJ open respiratory research. 2024-05-21;11(1) DOI : 10.1136/bmjresp-2023-001890 PMID: 38772900
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
November 2021 to May 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 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, according to the relevant Read 2, Systematized Nomenclature of Medicine- Clinical Terms (SNOMED-CT) and local Educational Management Information System (EMIS®) codes.
Inclusion and exclusion criteria
Inclusion criteria:
  • Inclusion criteria:
  • Participants with at least one diagnosis of COPD at age 35 years or above 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, according to the relevant Read 2, Systematized Nomenclature of Medicine- Clinical Terms (SNOMED-CT) and local Educational Management Information System (EMIS®) codes.
  • Most recent smoking status prior to index date (at any point in the participant’s medical history) of ‘current’ or ‘former’ smoker derived from all medical codes (Read 2, SNOMED or local EMIS® codes).
  • Record linked to the Hospital Episode Statistics (HES).
  • Continuously registered with a General practitioner (GP) practice for a minimum of 365 days prior to the index date and a minimum of 180 days following the index date.
  • MITT greater than or equal to (>=)1 overlapping days of supply with all three triple therapy components prior to the index date.
  • Participants with >=1 prescription observable of single inhaler FF/UMEC/VI (TRELEGY ELLIPTA) between 15-Nov-2017 and 30-Sep-2019 following MITT. The index date will be defined as the earliest observable prescription for FF/UMEC/VI (TRELEGY ELLIPTA).
  • For primary/main analysis: a) Minimum of 6 months continual MITT use prior to treatment switch/initiation of single inhaler FF/UMEC/VI (TRELEGY ELLIPTA). b) Minimum of 6 months continual single inhaler FF/UMEC/VI (TRELEGY ELLIPTA) use following index date. Exclusion criteria:
  • At least one diagnostic code (Read 2, SNOMED-CT, local EMIS®, International Classification of Diseases version 10 [ICD-10]) of any medical condition that is 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.
  • Single inhaler FF/UMEC/VI or Beclomethasone dipropionate/ Fluticasone Furoate/Glycopyrronium Bromide (BDP/FF/GB) prescribed in the 12 months prior to the index date.
  • Use of an ELLIPTA device as part of MITT regimen (RELVAR® ELLIPTA® [FF/VI], ANORO® ELLIPTA® [UMEC/VI], INCRUSE® ELLIPTA® [UMEC]), ARNUITY® ELLIPTA® [FF].

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Study report synopsis
Available language(s): English
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Protocol
Available language(s): English
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Statistical analysis plan
Available language(s): English
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Scientific result summary
Available language(s): English
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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
2022-25-05
Actual study completion date
2022-25-05

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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