Last updated: 03/29/2021 11:10:07

Observational retrospective cohort study, comparing outcomes in Salford, UK (data source: SLS) with rest of UK (data source: CPRD) over a 12 month period

GSK study ID
201491
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: Observational retrospective cohort study, comparing outcomes in Salford, UK (data source: SLS) with rest of UK (data source: CPRD) over a 12 month period
Trial description: The Salford Lung Study (SLS) is a unique Phase IIIB / IV observational pragmatic trial evaluating the effectiveness of RELVAR (fluticasone furoate [FF], GW685698) and vilanterol [VI] GW642444) compared with standard of care COPD treatments among patients with Chronic Obstructive Pulmonary Disease (COPD). The trial is taking place in Salford, England. While the pragmatic nature of the trial is designed to test effectiveness in routine care, there are at least two possible concerns: 1) Salford may not be representative of the wider population in which the medicine may be used, and 2) there may be differences in local practice or changes to local practice caused by the study (the Hawthorne effect), which may artificially inflate the benefits of both RELVAR and standard of care treatment. The aim of this study is to evaluate the representativeness of Salford, and the potential Hawthorne effect, to place the SLS in wider context. This is an observational retrospective cohort study, comparing outcomes in Salford, UK (data source: SLS) with rest of UK (data source: CPRD) over a 12 month period. The target sample size for the SLS is 2,800. Study size in the CPRD will be based on the prevalence of COPD diagnosis codes; this will be at minimum 2,800 as patients will be matched, but is expected to be considerably larger.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

To characterize the patients enrolled in the Standard of Care arm of SLS compared with the UK population of COPD patients (using the Clinical Practice Research Datalink [CPRD]).

Timeframe: For a period of 12 months after index date (date of entry into SLS or matched date for CPRD; referred to as 12 month study follow-up period).

The rate of COPD exacerbation over the 12 months in the Standard of Care arm of the SLS compared with the standard of care recorded in the CPRD, in order to detect a potential Hawthorne effect.

Timeframe: For a period of 12 months after index date (date of entry into SLS or matched date for CPRD; referred to as 12 month study follow-up period).

The rate of serious pneumonia (defined by hospitalisation) over the 12 months in the Standard of Care arm of the SLS compared with the standard of care recorded in the CPRD

Timeframe: For a period of 12 months after index date (date of entry into SLS or matched date for CPRD; referred to as 12 month study follow-up period).

Secondary outcomes:

Healthcare utilisation as assessed by all general physician visits/encounters and all hospital admissions

Timeframe: For 12 months study follow-up period

Adherence to index prescription as assessed by calculation of percent days covered, medication possession ratio, discontinuation, switching medicine or adding on other medicines

Timeframe: For 12 months study follow-up period

Number of deaths: All cause, pneumonia death, COPD-attributed death

Timeframe: For 12 months study follow-up period

COPD exacerbations

Timeframe: For 12 months study follow-up period

Interventions:
  • Other: The primary exposure of interest is enrollment in the Salford Lung Study standard of care arm
    • Enrollment:
    5600
    Primary completion date:
    2017-27-08
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Alexander Pate, Michael Barrowman, Dave Webb, Jeanne M Pimenta, Kourtney J Davis, Rachael Williams, Tjeerd Van Staa, Matthew Sperrin. A study investigating the generalisbility of a COPD trial based in English primary care (Salford Lung Study) found it was comparable to its target population, with Hawthorne effect observed through behavioural changes. BMJ Open Respir Res. 2018;5(1) DOI: 10.1136/bmjresp-2018-000339 PMID: 30397486
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
    Collaborators
    Not applicable
    Study date(s)
    October 2015 to August 2017
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    Not applicable
    • For the SLS Standard of Care arm:
    • Patients randomised to Standard of Care arm only.
    • For the SLS Standard of Care arm:
    • Patients randomised to the RELVAR arm.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • For the SLS Standard of Care arm:
    • Patients randomised to Standard of Care arm only. For the CPRD comparison cohort:
    • Diagnosis of COPD within clinical or referral files of CPRD
    • At least one day of up-to-standard (UTS) practice registration aged >=40.
    • Eligible for linkage to Hospital Episode Statistics (HES), deprivation and Office of National Statistics (ONS) data. Following this, restricted cohorts will be generated according to inclusion criteria of the SLS:
    • Patients with documented GP diagnosis of COPD, and currently receiving maintenance therapy, defined as follows: inhaled corticosteroid (ICS) alone or in combination with a long acting bronchodilator (this could be a fixed dose combination or an ICS/Long acting beta agonist [LABA] provided in two separate inhalers, or ICS and long acting muscarinic antagonist [LAMA], or long-acting ronchodilator therapy alone (e.g. tiotropium or salmeterol, or the use of two bronchodilators i.e. LABA/LAMA), or “triple therapy” i.e. ICS/LABA plus a LAMA.
    • Male or female subjects aged 40 years of age at index date.
    • Patients who have a history of treatment with systemic/oral corticosteroids, antibiotics (in association with general physician contact) and/or hospitalisation for at least one COPD exacerbation in the 3 years prior to index date.
    Exclusion criteria:
    • For the SLS Standard of Care arm:
    • Patients randomised to the RELVAR arm. For CPRD comparison cohort: There are no exclusion criteria for the initial CPRD cohort. Subjects meeting any of the following criteria will not be included in the restricted CPRD cohort:
    • Patients with any life threatening condition or uncontrolled/clinically significant disease.
    • Patients with unstable COPD: Patients with an exacerbation (defined by treatment with oral corticosteroids and/or antibiotic or hospital discharge listing COPD) with an onset within 2 weeks of index date. Delay index date until at least 2 weeks after the onset of an exacerbation and until the exacerbation has resolved.
    • Chronic user of oral corticosteroids: Subjects who are considered to be a chronic user of oral corticosteroids for respiratory or other indications.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Protocol
    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
    2017-27-08
    Actual study completion date
    2017-27-08

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website