Last updated: 07/28/2020 05:40:16

Retrospective study of asthma patients prescribed with ICS/LABA maintenance medications using a Japan Medical Data Center (JMDC) Claim database in Japan

GSK study ID
207264
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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: Retrospective study of asthma patients prescribed with ICS/LABA maintenance medications using a Japan Medical Data Center (JMDC) Claim database in Japan
Trial description: Budesonide/formoterol (BUD/FO), Fluticasone furoate/vilanterol (FF/VI) and Fluticasone propionate/ formoterol (FP/FO), are widely used for asthma treatment in Japan. However, it is not clear how ICS/LABA treatment is used by different types of physicians, institutions and patients. Once daily ICS/LABA (FF/VI) is now available and the impact of once daily FF/VI on adherence compared to existing twice daily ICS/LABA has not yet been evaluated. Patient adherence is a key factor influencing asthma control. Improved adherence result in improved asthma control. Adherence is person’s behavior of taking medication, it is difficult to investigate adherence in the study. Therefore, medication compliance is used for indicator of treatment adherence. This will be a non-interventional, retrospective cohort study, to describe actual usage of ICS/LABA and investigate difference of the medication compliance between subjects prescribed with FF/VI and those with twice-daily ICS/LABA using the JMDC claims database. The study will be conducted in 2 steps. Step 1 aims to describe the characteristics, information on medical facility, healthcare resource utilization, short-acting beta2-agonist (SABA) use, oral corticosteroids (OCS) use and asthma exacerbation of subjects who are prescribed with ICS/LABA, ICS mono and non ICS in the pre-index and post-index period. Feasibility check will be performed based on the results in step 1 to determine whether or not to proceed to step 2. The aim of the step 2 is to compare the medication compliance between FF/VI, a once-daily ICS/LABA, and FP/SLM, a twice-daily ICS/LABA. Study will progress to step 2 only if subject numbers of FF/VI and Fluticasone propionate/salmeterol (FP/SLM) with ICS/LABA naïve will be 200 and more. As for period of ICS/LABA naivety, 12 months will be used in default. However, 6 months will be used as an alternative if subject numbers of 12 months are less than 200.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

NUMBER OF PARTICIPANTS WITH CHARACTERISTICS, INFORMATION ON MEDICAL FACILITY, SABA USE, OCS USE AND ASTHMA EXACERBATION IN THE OVERALL ASTHMA, ICS MONO, NON ICS, AND ICS/LABA IN PRE-INDEX AND POST-INDEX PERIOD IN STEP 1

Timeframe: 1 year

NUMBER OF PRESCRIBED DAYS PER YEAR BETWEEN FF/VI AND FP/SLM DISKUS (DK) OR PRESSURIZED METERED DOSE INHALER (PMDI) IN THE ICS/LABA NAÏVE COHORT IN THE POST-INDEX PERIOD IN STEP 2

Timeframe: 1 year

PROPORTION OF DAYS COVERED (PDC) BETWEEN FF/VI AND FP/SLM DK OR PMDI IN THE ICS/LABA NAÏVE COHORT IN THE POST-INDEX PERIOD IN STEP 2

Timeframe: 1 year

Secondary outcomes:

NUMBER OF PARTICIPANTS WITH CHARACTERISTICS, INFORMATION ON MEDICAL FACILITY AND HEALTHCARE RESOURCE UTILIZATION IN FP/SLM PMDI, FP/SLM DK, BUD/FO, FP/FO, AND FF/VI IN IN PRE-INDEX PERIOD STEP 1

Timeframe: 1 year

NUMBER OF PARTICIPANTS WITH CHARACTERISTICS, INFORMATION ON MEDICAL FACILITY AND HEALTHCARE RESOURCE UTILIZATION IN FP/SLM DK AND FF/VI BEING ICS/LABA NAÏVE IN PRE-INDEX PERIOD IN STEP 1

Timeframe: 1 year

NUMBER OF PARTICIPANTS WITH CHARACTERISTICS, INFORMATION ON MEDICAL FACILITY AND HEALTHCARE RESOURCE UTILIZATION IN FP/SLM DK 100, FP/SLM DK 250, FP/SLM DK 500, FP/SLM PMDI 50, FP/SLM PMDI 125, FP/SLM PMDI 250, FF/VI 100 AND FF/VI 200 IN STEP 1

Timeframe: 1 year

NUMBER OF PARTICIPANTS WITH SABA USE, OCS USE AND PERSISTENT VISIT BETWEEN FF/VI AND FP/SLM DK OR PMDI IN THE ICS/LABA NAÏVE COHORT IN THE POST-INDEX PERIOD IN STEP 2

Timeframe: 1 year

PROPORTION OF COMPLIANT AND NON-COMPLIANT BETWEEN FF/VI AND FP/SLM DK IN THE ICS/LABA NAÏVE COHORT IN THE POST-INDEX PERIOD IN STEP 2

Timeframe: 1 year

Interventions:
  • Drug: FP/SLM pMDI
  • Drug: SABA
  • Drug: FF/VI
  • Drug: BUD/FO
  • Drug: FP/FO
  • Drug: Ciclesonide
  • Drug: BDP mono
  • Drug: Theophillin
  • Drug: FP/SLM PMDI 50
  • Drug: FP mono
  • Drug: FF/VI 200
  • Drug: LTRA
  • Drug: FP/SLM PMDI 250
  • Drug: FP/SLM DK
  • Drug: FP/SLM DK 500
  • Drug: FP/SLM DK 100
  • Drug: BUD mono
  • Drug: FP/SLM PMDI 125
  • Drug: FF/VI 100
  • Drug: FP/SLM DK 250
  • Drug: Mometasone
    • Enrollment:
    1
    Primary completion date:
    2018-09-02
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Ryo Atsuta, Jun Takai, Isao Mukai, Akihiro Kobayashi, Takeo Ishii, and Henrik Svedsater. Patients with Asthma Prescribed Once-Daily Fluticasone Furoate/Vilanterol or Twice-Daily Fluticasone Propionate/Salmeterol as Maintenance Treatment: Analysis from a Claims Database. Pulm Ther. 2018;4(6):1-13
    Ryo Atsuta, Jun Takai, Isao Mukai, Akihiro Kobayashi, Takeo Ishii, and Henrik Svedsater.Patients with Asthma Prescribed Once-Daily Fluticasone Furoate/Vilanterol or Twice-Daily Fluticasone Propionate/Salmeterol as Maintenance Treatment: Analysis from a Claims Database.Pulm Ther.2018;4(2):135-147 DOI: 10.1007/s41030-018-0084-4
    Medical condition
    Asthma
    Product
    fluticasone furoate, fluticasone furoate/vilanterol, fluticasone propionate, fluticasone propionate/salmeterol, salmeterol, vilanterol
    Collaborators
    Department of Respiratory Medicine, Juntendo Tokyo Koto Geriatric Medical Center, Japan Medical Data Center Co., Ltd.
    Study date(s)
    July 2017 to February 2018
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    15+ years
    Accepts healthy volunteers
    Not applicable
    • 1 claim with asthma and 1 prescription of asthma drugs (ICS [/LABA], Leukotriene receptor antagonist [LTRA], Theophylline and SABA) between December 2014 and October 2015 (defined as day 0).
    • Continuous enrollment in JMDC database before and after 1 year from day 0
    • We have no exclusion criteria in this study.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • 1 claim with asthma and 1 prescription of asthma drugs (ICS [/LABA], Leukotriene receptor antagonist [LTRA], Theophylline and SABA) between December 2014 and October 2015 (defined as day 0).
    • Continuous enrollment in JMDC database before and after 1 year from day 0
    • Age 15 years old and more at the time of day 0
    • >=1 additional prescription of asthma drugs (ICS [/LABA], LTRA, Theophylline and SABA) between day 0 and day +365 other than day 0.
    • >=1 claim with asthma and >=1 prescription of asthma drugs between day -1 and -364 asthma drugs include ICS (/LABA), LTRA, Theophylline and SABA.
    • Since it is difficult to confirm asthma diagnosis and claim is not based on confirmed diagnosis in Japan, subject with only 1 claim with asthma may contain other disease. Therefore, “>=2 prescriptions of asthma drugs in observation period” will be used for inclusion criteria in this study.
    Exclusion criteria:
    • We have no exclusion criteria in this study.

    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
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    Statistical analysis plan
    Available language(s): English
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    Scientific result summary
    Available language(s): English
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    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
    2018-09-02
    Actual study completion date
    2018-09-02

    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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