An observational evaluation of prescribing of fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist (ICS/LABA): fluticasone propionate / formoterol (FP/FOR) and adverse events in routine primary care at 18-months and 36-months post launch

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Flutiform, Seretide, Symbicort, Fostair
• Medical condition to be studied:
  Asthma

  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  Patients ≥4 years old captured in CPRD during the period from 25th September 2015 until 24th September 2015 (i.e. 36-months post UK launch of fluticasone propionate /formoterol (FP/FOR), where FP/FOR launch was on 25th September 2012) who initiated on any FDC ICS/LABA [including FP/FOR, fluticasone/salmeterol (FP/SAL), budesonide/formoterol (BUD/FOR), beclomethasone/formoterol (BDP/FOR)].
• Age groups:
  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)
• Special population of interest:
  Other
• Special population of interest, other:
  Asthma, Chronic obstructive pulmonary disease patients
• Estimated number of subjects:
  3500

Study design details

• Main study objective:
  To quantify the prevalence of on and off-label prescribing of FP/FOR and other FDC ICS/LABA therapies.To evaluate adverse events in patients prescribed FP/FOR versus other FDC ICS/LABA therapies for both licensed and off-label groups.
• Outcomes:
  Prevalence of on and off-label prescribing of FP/FOR and other FDC ICS/LABA therapies.Adverse events in patients prescribed FP/FOR versus other FDC ICS/LABA therapies for both licensed and off-label groups. Demographic, medication and disease-related characteristics for patients prescribed FP/FOR and other FDC ICS/LABA therapies.
• Data analysis plan:
  Number of patients prescribed FP/FOR and each FDC ICS/LABA will be tabulated and detailed as a percentage of (a) all patients captured in CPRD during the time period 18/36-months post UK launch of FP/FOR and (b) each of the licensed/off-label subgroups.First occurrence of an adverse event per patient analysed: Annualised rate of each adverse event per 100 patients and time to each adverse event will be compared across FDC ICS/LABA therapies using Kaplan-Meier survival curves and, if appropriate, hazard ratios.Multiple occurrences of an adverse event per patient: Mean/median (as appropriate) number of each adverse event per patient.

Documents

Study results

160714_R02213_Flutiform offlabel and AEs_Stage 1_Final report_v2.0 (1)

160829_R02213_Flutiform offlabel and AEs_Stage 2_Final report_v1.1 (1)