Last updated: 08/07/2026 10:00:48
Comparing BDP/FOR/GLY vs FF/UMEC/VI for COPD Exacerbations in Adults With COPD in the UK
GSK study ID
302097
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Planned
Planned
Trial overview
Official title: Comparing BDP/FOR/GLY vs FF/UMEC/VI for COPD Exacerbations in Adults With COPD in the UK
Trial description: This study uses health records from people in the United Kingdom to understand how two commonly used COPD inhalers perform in everyday clinical practice. It compares how often patients experience exacerbations (flare-ups), how quickly they occur after starting treatment, their use of healthcare services, and long-term outcomes. By looking at real-world data, the study aims to provide practical insights into treatment effectiveness. Before the main analysis, researchers will assess whether the available data are sufficient to ensure a fair and reliable comparison between the two treatments.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Annual Rate of COPD Exacerbations Among Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) versus Beclometasone Dipropionate, Formoterol Fumarate Dihydrate, Glycopyrronium Bromide (BDP/FF/G) Initiators
Timeframe: Up to approximately 7.3 years
Secondary outcomes:
Time to First COPD Exacerbation
Timeframe: Up to approximately 7.3 years
Annual rate of COPD Exacerbation Among FF/UMEC/VI versus BDP/FF/G Initiators Divided by History of Prior COPD Exacerbations
Timeframe: Up to approximately 7.3 years
Time to First Severe COPD Exacerbation Among FF/UMEC/VI versus BDP/FF/G Initiators Divided by History of Prior COPD Exacerbations
Timeframe: Up to approximately 7.3 years
Annual rate of COPD Exacerbation Among FF/UMEC/VI versus BDP/FF/G Initiators grouped by Most Recent Class of Dual Therapy
Timeframe: Up to approximately 7.3 years
Time to First Severe COPD Exacerbation Among FF/UMEC/VI versus BDP/FF/G Initiators Grouped by Most Recent Class of Dual Therapy
Timeframe: Up to approximately 7.3 years
Interventions:
Not applicable
Enrollment:
Not applicable
Observational study model:
Cohort
Primary completion date:
2026-30-10
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Chronic obstructive pulmonary disease
Product
vilanterol
Collaborators
Not applicable
Study date(s)
September 2026 to October 2026
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- At least one recorded prescription of Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) or Beclometasone Dipropionate, Formoterol Fumarate Dihydrate, Glycopyrronium Bromide (BDP/FF/G) on or after January 1, 2018
- Linkage to Hospital Episode Statistics (HES) and Office for National Statistics (ONS)
- Less than (<) 40 years of age on the index date
- Greater than or equal to (>=)1 prescription of FF/UMEC/VI or BDP/FF/G, or other triple therapy (e.g., Trixeo Aerosphere, Riltrava Aerosphere), any time prior to the index date (to ensure patients are newly initiated on Single-Inhaler Triple Therapy [SITT])
Inclusion and exclusion criteria
Inclusion criteria:
- Linkage to Hospital Episode Statistics (HES) and Office for National Statistics (ONS)
- Most recent maintenance controller medication in the last 90 days preceding initiation of index therapy was Inhaled Corticosteroid (ICS)/ Long-Acting beta 2-Agonists (LABA) or Long-Acting Muscarinic Antagonists (LAMA)/LABA
- At least two separate dates with a diagnosis of COPD in any position and in any care setting during the baseline period or on the index date
- At least 12 months of registry in the clinical practice database prior to the index date
At least one recorded prescription of Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) or Beclometasone Dipropionate, Formoterol Fumarate Dihydrate, Glycopyrronium Bromide (BDP/FF/G) on or after January 1, 2018
Exclusion criteria:
- Greater than or equal to (>=)1 prescription of FF/UMEC/VI or BDP/FF/G, or other triple therapy (e.g., Trixeo Aerosphere, Riltrava Aerosphere), any time prior to the index date (to ensure patients are newly initiated on Single-Inhaler Triple Therapy [SITT])
- Prescription for both FF/UMEC/VI and BDP/FF/G on the index date
- >=1 diagnosis of asthma in any position during the baseline period
- >=1 diagnosis of cystic fibrosis, lung cancer, interstitial lung disease, or alpha-1 antitrypsin deficiency in any position during the baseline period
- >=1 prescription for a respiratory biologic (i.e., mepolizumab or dupilumab) during the baseline period or on the index date
Less than (<) 40 years of age on the index date
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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