Last updated: 10/31/2025 12:20:09

Comparison of clinical outcomes of participants with asthma on fluticasone furoate/vilanterol and budesonide/formoterol treatment

GSK study ID
221182
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: A comparison of clinical outcomes in patients with asthma between patients on fluticasone furoate/vilanterol (Relvar) and budesonide/formoterol (Symbicort) as routine clinical practice in England
Trial description: The study aimed to compare the real-world effectiveness of fluticasone furoate/vilanterol (FF/VI) versus budesonide/formoterol (BUD/FOR) in management and healthcare resource utilization (HCRU) outcomes in participants with asthma, utilizing linked Clinical Practice Research Datalink Aurum and Hospital Episode Statistics (HES) datasets in the England. The index date will be defined as the first/earliest prescription date of a single device FF/VI or BUD/FOR inhaler within the indexing period of 01 December 2015 and 28 February 2019, where no fixed-dose Inhaled corticosteroid (ICS)/ Long-acting beta-agonist (LABA) prescriptions are observed in the prior 12 months. RELVAR is a registered trademark of GlaxoSmithKline group of companies. SYMBICORT is a trademark of AstraZeneca AB.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of overall asthma exacerbations

Timeframe: Up to 12 months

Secondary outcomes:

Time to first asthma exacerbation

Timeframe: Up to 12 months

Number of severe asthma exacerbation

Timeframe: Up to 12 months

Number of asthma exacerbations stratified by for dose groups of FF/VI and BUD/FOR

Timeframe: Up to 12 months

Number of Short-acting beta-agonist (SABA) canisters per participant per year

Timeframe: Up to 12 months

Total all cause HCRU and Total asthma related HCRU

Timeframe: Up to 12 months

Number of participants receiving dose of oral corticosteroids (OCS)

Timeframe: Up to 12 months

Treatment persistence and Treatment adherence to FF/VI versus BUD/FOR

Timeframe: Up to 12 months

Time to first non-persistence of indexed therapy

Timeframe: Up to 12 months

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2024-28-11
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Ashley Woodcock, John Blakey, Arnaud Bourdin, Giorgio Walter Canonica, Christian Domingo, Alexander Ford, Rosie Hulme, Theo Tritton, Ines Palomares, Sanchayita Sadhu, Arunangshu Biswas, Manish Verma. Real-world Comparative Effectiveness in Patients with Asthma Newly Initiating Fluticasone Furoate/Vilanterol or Budesonide/Formoterol: A United Kingdom General Practice Cohort Study. Pulmonary therapy. 2025-Sep-16; doi:10.1007/s41030-025-00313-2 http://dx.doi.org/10.1007/s41030-025-00313-2 PMID: 40956480 DOI: 10.1007/s41030-025-00313-2
Medical condition
Asthma
Product
Not applicable
Collaborators
Adelphi Real World
Study date(s)
September 2024 to November 2024
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • At least one prescription of either single device FF/VI or BUD/FOR inhaler within the index period. The first/earliest such prescription within the index period will define the index date.
  • At least one diagnosis of asthma (defined according to a validated algorithm) at any time in the participant history prior to and including the index date.
  • More than one fixed-dose ICS/LABA therapy prescribed on the index date.
  • One or more prescriptions for any fixed-dose ICS/LABA therapy within the Baseline period.
Inclusion and exclusion criteria
Inclusion criteria:
  • At least one prescription of either single device FF/VI or BUD/FOR inhaler within the index period. The first/earliest such prescription within the index period will define the index date.
  • At least one diagnosis of asthma (defined according to a validated algorithm) at any time in the participant history prior to and including the index date.
  • At least one prescription for a SABA inhaler in the 6 months prior to and including the index date.
  • 18 years of age or older at index date.
  • Continuously registered with a general practitioner practice for a minimum of 12 months prior to the index date.
  • Participant’s record eligible for linkage to HES and Index of Multiple Deprivation (IMD).
Exclusion criteria:
  • More than one fixed-dose ICS/LABA therapy prescribed on the index date.
  • One or more prescriptions for any fixed-dose ICS/LABA therapy within the Baseline period.
  • One or more separate prescriptions of ICS and one or more separate prescription of LABA within the Baseline period
  • One or more prescriptions of ICS/ Long-acting muscarinic antagonist (LAMA)/LABA single inhaler triple therapy within the Baseline period.
  • At least one diagnostic code for chronic obstructive pulmonary disease at any time prior to index.
  • At least one diagnostic code of any medical conditions incompatible with an asthma diagnosis at any time in the participant’s medical history, i.e. i. Conditions that are related to lung or bronchial developmental anomalies and degenerative processes such as bronchiolitis obliterans, cystic fibrosis, pulmonary fibrosis (not pulmonary hypertension), pulmonary resection. ii. Other significant respiratory disorders other than asthma that can interfere with clinical asthma diagnosis or substantially change the natural history of the disease including chronic obstructive pulmonary diseases and acute respiratory failure.
  • One or more prescriptions of a biologic therapy within the Baseline or follow up period.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Study report synopsis
Available language(s): English
Download document(s)
Protocol
Available language(s): English
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Statistical analysis plan
Available language(s): English
Download document(s)
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
2024-28-11
Actual study completion date
2024-28-11

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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