Drug utilisation study of new users of fluticasone furoate / vilanterol (FF/VI) in the primary care setting: UK Clinical Practice Research Datalink (CPRD) study (205052)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Other
• If ‘other’, further details on the scope of the study:
  Off-label use
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective, longitudinal, non-interventional, observational study

Study drug and medical condition

• Name of medicine:
  RELVAR

  REVINTY
• Study drug International non-proprietary name (INN) or common name:
  FLUTICASONE FUROATE

  VILANTEROL TRIFENATATE
• Anatomical Therapeutic Chemical (ATC) code:
  (R03AK10) vilanterol and fluticasone furoate

  vilanterol and fluticasone furoate
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

  Asthma

Population studied

• Short description of the study population:
  The main study population consisted of new users of FF/VI or other ICS/LABA FDC medications with ‘acceptable’ data quality in CPRD-GOLD. Patients are labelled as ‘acceptable’ if they have continuous follow up and do not meet criteria for poor data recording.; Inclusion criteria:; - Record of a new prescription of FF/VI or other ICS/LABA FDC during the inclusion period (January 1, 2014 through December 31, 2015).; - ≥ 12 months of registration at a practice with ‘up to standard data’ recording prior to index prescription date to allow for characterization of patient’s status, demographics and clinical characteristics. Data are considered ‘up to standard’ when the GP practice has continuous high quality data fit for use in research.; Exclusion criteria:; - Patients were excluded if they had ever had a prescription for the same specific inclusion medication prior to the index prescription. Prior use of another ICS/LABA FDC product was permitted. All available data prior to the index date was used to ascertain new use of FF/VI and other ICS/LABA FDC. Concomitant use of respiratory medications was allowed.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  4220

Study design details

• Main study objective:
  Off-label use and treatment patterns of FF/VI as well as patient characteristics will be evaluated in study with the use of UK primary care Electronic Medical Records (EMR) database
• Outcomes:
  Patient characteristics (including demographics and clinical characteristics), off-label prescribing, treatment patterns and adherence to therapy.
• Data analysis plan:
  Objective 1Among the new users of FF/VI or other ICS/LABA FDC patient demographics, comorbidities and disease history characteristics at date of index prescription will be summarised by diagnosis group. Objective 2Among the new users of FF/VI calculate the proportion with off label use according to pre-specified definitions.Objective 3Among the new users of FF/VI describe treatment patterns (discontinuation, switching and augmentation) and adherence to treatment using medication possession ratio proportion of days covered during follow-up.

Documents

Study results

gsk-205052-clinical-study-report-redact