Last updated: 07/28/2020 06:00:11

Assessment of FF/VI and other ICS/LABA’s on overall healthcare costs and outcomes in patients with COPD in the US

GSK study ID
206702
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: Assessment of FF/VI and other ICS/LABA’s on overall healthcare costs and outcomes in patients with COPD in the US
Trial description: Real-world information on treatment patterns, exacerbations and other outcomes among COPD patients who are treated with FF/VI relative to other inhaled corticosteroid (ICS)/long-acting β-agonist (LABA’s) combination medications in the United States (US) is limited. This is a retrospective database study, which will examine treatment patterns, exacerbations, health care utilization and costs among participants initiating treatment with ICS/LABA combination medications, specifically, FF/VI versus budesonide (B)/formoterol (F).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

COPD-related health care costs

Timeframe: Up to 35 months

Secondary outcomes:

All-cause health care costs

Timeframe: Up to 35 months

Time to COPD-related exacerbation

Timeframe: Up to 35 months

Number of COPD/asthma exacerbation episodes

Timeframe: Up to 35 months

Interventions:
  • Drug: Fluticasone Furoate
  • Drug: Formoterol
  • Drug: Vilanterol
  • Drug: Budesonide
    • Enrollment:
    1
    Primary completion date:
    2017-30-08
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Richard H. Stanford, Emily D. Parker, Tyler K. Reinsch, Ami R. Buikema, Cori Blauer-Peterson. Assessment of COPD-related outcomes in patients initiating a once daily or twice daily ICS/LABA. Respir Med. 2019;150:1-7 DOI: 10.1016/j.rmed.2019.01.019
    Medical condition
    Chronic obstructive pulmonary disease
    Product
    budesonide, budesonide/formoterol, fluticasone furoate, fluticasone furoate/vilanterol, formoterol, vilanterol
    Collaborators
    Not applicable
    Study date(s)
    December 2016 to August 2017
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    Not applicable
    • Pharmacy claim for FF/VI or B/F, the first observed claim during the participant identification period will be the index date
    • Age 40 years or older on index date
    • Use of index medication during baseline period
    • ICS/LABA use in baseline period
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Pharmacy claim for FF/VI or B/F, the first observed claim during the participant identification period will be the index date
    • Age 40 years or older on index date
    • Diagnosis of COPD (The International Classification of Diseases, Ninth Revision, Clinical Modification Diseases [ICD-9-CM] 491.xx, 492.xx or ICD-10-CM J41, J42, J43, J44)
    • At least 12 months continuous enrollment in health plan prior to the index date; a variable will be created to identify participants with baseline continuous enrollment of at least 24 months
    • At least 3 months continuous enrollment in the follow-up period
    Exclusion criteria:
    • Use of index medication during baseline period
    • ICS/LABA use in baseline period
    • Initiation of other respiratory meds on (or near) index date Diagnosis of acute respiratory failure (ICD-9-CM 518.81, ICD-10 CM J96.0, J96.2) during baseline or follow-up will be flagged.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
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    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
    2017-30-08
    Actual study completion date
    2017-30-08

    Plain language summaries

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

    Additional information about the trial

    Not applicable
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