Last updated: 12/03/2023 09:40:37
Comparative Effectiveness of Umeclidinium/Vilanterol Versus Indacaterol/Glycopyrronium Bromide In Participants With Chronic Obstructive Pulmonary Disease (COPD) In Real World
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Comparative effectiveness of Umeclidinium/Vilanterol versus Indacaterol/ Glycopyrronium bromide among patients with Chronic Obstructive Pulmonary Disease in a real-world primary care setting in the UK
Trial description: The purpose of this study is to assess non-inferiority and potentially superiority of Umeclidinium/vilanterol (UMEC/VI) versus Indacaterol/glycopyrronium (IND/GLY) on the rate of the overall moderate-to-severe acute exacerbations of COPD among participants newly initiating single device UMEC/VI and IND/GLY inhalers from a general practice (GP) cohort in England.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Rate of Overall Moderate-to-Severe Acute Exacerbations of COPD (AECOPDs)
Timeframe: Up to 24 months
Secondary outcomes:
Rate of Moderate AECOPDs
Timeframe: Up to 24 months
Rate of Severe AECOPDs
Timeframe: Up to 24 months
Time-to-First On-Treatment AECOPD (Overall, Moderate or Severe)
Timeframe: At months 3, 6, 9, 12, 18 and 24
All-Cause and COPD-Related Health Care Resource Utilisation (HCRU) and Direct Medical Costs
Timeframe: Up to 24 months
Interventions:
Enrollment:
0
Primary completion date:
2022-15-03
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide, vilanterol, umeclidinium bromide/vilanterol
Collaborators
Not applicable
Study date(s)
January 2022 to March 2022
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
35+ years
Accepts healthy volunteers
No
- Participant with at least one diagnostic code in the primary care setting (Systematized Nomenclature of Medicine - Clinical Terms [SNOMED-CT] or local EMIS® code) of COPD (i.e. Clinical Practice Research Datalink [CPRD] Aurum) at any time in the participant history prior to the index date.
- Participant with at least one prescription of a single device UMEC/VI or IND/GLY inhaler within the indexing period with a prior COPD diagnosis.
- Participant with at least one diagnostic code (SNOMED-CT, local EMIS®, or International Classification of Diseases version 10 [ICD-10] code) of any medical conditions incompatible with a COPD diagnosis at any time in the 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.
- Participant with a prescription for both UMEC/VI and IND/GLY on the index date.
Inclusion and exclusion criteria
Inclusion criteria:
- Participant with at least one diagnostic code in the primary care setting (Systematized Nomenclature of Medicine
- Clinical Terms [SNOMED-CT] or local EMIS® code) of COPD (i.e. Clinical Practice Research Datalink [CPRD] Aurum) at any time in the participant history prior to the index date.
- Participant with at least one prescription of a single device UMEC/VI or IND/GLY inhaler within the indexing period with a prior COPD diagnosis.
- Participant with a forced expiratory volume in one second (FEV1) / forced vital capacity (FVC) <0.7 at any time in the participant history prior to and including the index date.
- Participant with record linked to Hospital Episode Statistics (HES).
- Participant should be continuously registered with a GP practice for a minimum of 12 months (365.25 days) prior to the index date.
Exclusion criteria:
- Participant with at least one diagnostic code (SNOMED-CT, local EMIS®, or International Classification of Diseases version 10 [ICD-10] code) of any medical conditions incompatible with a COPD diagnosis at any time in the 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.
- Participant with a prescription for both UMEC/VI and IND/GLY on the index date.
- Participant with one or more prescriptions for any single-device or open combinations of Long-acting beta-agonist (LABA) + Long-acting muscarinic antagonist (LAMA) dual therapy prior to index.
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
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
2022-15-03
Actual study completion date
2022-15-03
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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