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

GSK study ID
217815
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: 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
    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
    • 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)

    This study does not involve prospective enrollment of participants.

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    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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