Last updated: 07/28/2020 05:50:29

HO-16-17302 - Assessment of adherence and costs in asthma patients using ICS/LABA in the US

GSK study ID
206482
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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: HO-16-17302 - Assessment of adherence and costs in asthma patients using ICS/LABA in the US
Trial description: This study will examine treatment patterns, exacerbations, health care utilization and costs among subjects with asthma initiating treatment with inhaled corticosteroid (ICS)/ Long-acting beta-agonists (LABA) combination medications, specifically, fluticasone furoate (FF)/vilanterol (VI) versus budesonide (BU)/formoterol (FO). This will be a retrospective database analysis to examine treatment patterns. This retrospective cohort study will include commercial and Medicare Advantage subjects treated with FF/VI or BU/FO between 10-May-2013 and 31-Mar-2016. The study will use medical data, pharmacy data, and enrollment information in the Optum Research Database (ORD).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Proportion of days covered (PDC)

Timeframe: Up to 12 months

Secondary outcomes:

Number of discontinuations of index therapy

Timeframe: Up to 12 months

Asthma Medication Ratio (AMR)

Timeframe: Up to 12 months

Number of short-acting beta-agonist (SABA) canisters

Timeframe: Up to 12 months

Interventions:
  • Drug: Budesonide/Formoterol
  • Drug: Fluticasone/Vilanterol
    • Enrollment:
    3450
    Primary completion date:
    2016-16-12
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Richard H Stanford, Carlyne Averell, Emily D Parker, Cori Blauer-Peterson, Tyler K Reinsch, Ami R Buikema.Assessment of adherence and asthma medication ratio (AMR) for a once-daily and twice-daily inhaled corticosteroid/long acting beta agonist (ICS/LABA) for asthma.J Allergy Clin Immunol Pract.2019;7(5):1488-1499 DOI: 10.1016/j.jaip.2018.12.021 PMID: 30639604
    Medical condition
    Asthma
    Product
    fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
    Collaborators
    Not applicable
    Study date(s)
    October 2016 to December 2016
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    Not applicable
    • Pharmacy claim for FF/VI or BU/FO, the first observed claim during the subject identification period will be the index date
    • Age 18 years or older on index date
    • Use of the index medication during the baseline period
    • Diagnosis of cystic fibrosis (ICD-9-CM 277.0, ICD-10-CM E84.0-E84.9) during baseline or follow-up
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Pharmacy claim for FF/VI or BU/FO, the first observed claim during the subject identification period will be the index date
    • Age 18 years or older on index date
    • Diagnosis of asthma (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] 493.xx, International Classification of Diseases, Tenth Revision, Clinical Modification [ICD-10-CM] J (J denotes codes for respiratory disease) 45.3, J45.4, J45.5, J45.9) prior to or on the index date
    • At least 12 months continuous enrollment in health plan prior to the index date; a variable will be created to identify subjects with baseline continuous enrollment of at least 24 months
    • At least 3 months continuous enrollment in the follow-up period
    Exclusion criteria:
    • Use of the index medication during the baseline period
    • Diagnosis of cystic fibrosis (ICD-9-CM 277.0, ICD-10-CM E84.0-E84.9) during baseline or follow-up
    • Diagnosis of acute respiratory failure (ICD-9-CM 518.81, ICD-10 CM J96.0, J96.2) during baseline or follow-up

    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
    2016-16-12
    Actual study completion date
    2016-16-12

    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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