Last updated: 02/06/2024 06:01:01
Comparative Effectiveness of Umeclidinium/Vilanterol Versus Tiotropium Bromide/Olodaterol Among 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
Finalized
Finalized
Trial overview
Official title: Comparative effectiveness of Umeclidinium/Vilanterol versus Tiotropium Bromide/Olodaterol among patients with Chronic Obstructive Pulmonary Disease in a real-world primary care setting in the UK
Trial description: In this study the superiority on rescue medication use amongst participants newly initiating single device of Umeclidinium/vilanterol (UMEC/VI) and Tiotropium bromide/olodaterol (TIO/OLO) inhalers from a general practice (GP) cohort in England will be assessed. If superiority of UMEC/VI to TIO/OLO on the mean number of rescue medications prescribed cannot be demonstrated, the non-inferiority of UMEC/VI versus TIO/OLO will be examined.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Mean number of rescue medication prescriptions
Timeframe: 12 months following treatment initiation
Secondary outcomes:
Mean number of rescue medication prescriptions
Timeframe: 6, 18 and 24 months following treatment initiation
Medication adherence using the proportion of days covered (PDC)
Timeframe: 6, 12, 18 and 24 months following treatment initiation
Interventions:
Drug: Umeclidinium/Vilanterol
Drug: Tiotropium Bromide/Olodaterol
Enrollment:
0
Observational study model:
Cohort
Primary completion date:
2022-15-03
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
- At least one diagnostic code in the primary care setting of COPD (i.e., Clinical Practice Research Datalink [CPRD] Aurum) at any time in the participant history prior to the index date.
- At least one prescription of a single device UMEC/VI or TIO/OLO inhaler within the indexing period with a prior COPD diagnosis.
- At least one diagnostic code (Read 2, Systematised Nomenclature of Medicine - Clinical Terms [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 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.
- A prescription for both UMEC/VI and TIO/OLO on the index date.
Inclusion and exclusion criteria
Inclusion criteria:
- At least one diagnostic code in the primary care setting of COPD (i.e., Clinical Practice Research Datalink [CPRD] Aurum) at any time in the participant history prior to the index date.
- At least one prescription of a single device UMEC/VI or TIO/OLO inhaler within the indexing period with a prior COPD diagnosis.
- 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 index date.
- Record linked to Hospital Episode Statistics (HES).
- Continuously registered with a GP practice for a minimum of 12 months (365.25 days) prior to the index date.
Exclusion criteria:
- At least one diagnostic code (Read 2, Systematised Nomenclature of Medicine
- Clinical Terms [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 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.
- A prescription for both UMEC/VI and TIO/OLO on the index date.
- One or more prescriptions of any single-device or open combination of dual Long-acting beta-agonist (LAMA)/Long-acting muscarinic antagonist (LABA) therapy prior to the index date.
- One or more prescription of an ICS- or LABA-containing medication prior to the index date.
- Concomitant use of an ICS at index date.
Trial location(s)
No location data available.
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
Finalized
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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