Real-life effectiveness (and cost impact) evaluation of fixed-dose combination fluticasone propionate/formoterol (Flutiform®) for the management of asthma in a routine UK primary care population - Phase 1 (Real-life effectiveness of Flutiform® Phase 1)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective study

Study drug and medical condition

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

Population studied

• Short description of the study population:
  Asthma patients who had changed from fluticasone propionate / salmeterol (Seretide®; FP/SAL) to fluticasone propionate / formoterol (Flutiform®; FP/FOR)
• Age groups:
  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 patients
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  To evaluate the success of changing real-life asthma patients from fluticasone propionate / salmeterol (Seretide®, FP/SAL) to fluticasone propionate / formoterol (Flutiform®, FP/FOR)
• Outcomes:
  In this Phase 1 study, change success will be evaluated. Change success is defined as Percentage of FP/FOR patients who received ≥2 prescriptions of FP/FOR (i.e. ≥1 prescription in addition to that issued at IPD). If failed, the potential reasons for discontinuation will be evaluated including: (i) Occurrence of severe exacerbations within the 6-month period defined as:(ii) Loss of asthma control (in the subset of patients controlled at baseline) (iii) Adverse events
• Data analysis plan:
  GeneralStatistically significant results will be defined as p<0.05 and trends as 0.05≤p<0.10.All analyses will be carried out using SPSS version 19 89, SAS version 9.3 910 and Microsoft Office EXCEL 2007. Summary statisticsSummary statistics will be produced for all baseline and outcome variables, as a complete dataset and by treatment groups. For variables measured on the interval or ratio scale, these will include:• Sample size (n)• Percentage non-missing• Mean • Variance / Standard Deviation• Range (Minimum / Maximum)• Median• Inter-quartile Range (25th and 75th percentiles)For categorical variables, the summary statistics will include:• Sample size (n)• Range (if applicable)• Count and Percentage by category (distribution)

Documents

Study results

IPCRG14LB-1326-v2_Final_submitted_edited

Study, other information

R03212a_PCRS abstract_Real world effectiveness Seretide_Napp_2014-06-06_FINAL submitted

R03212a_REG poster abstract_Real world effectiveness Flutiform_Napp_2014-06-06_FINAL

Study publications

Global Initiative for Asthma

Politiek MJ, Boorsma M, Aalbers R. Comparison of formoterol, salbutamol and sal…

Masoli M, Fabian D, Holt S, Beasley R, Global Initiative for Asthma (GINA) Prog…

Demoly P, Gueron B, Annunziata K, Adamek L, Walters RD. Update on asthma contro…

Bahadori K, Doyle-Waters MM, Marra C, Lynd L, Alasaly K, Swiston J, FitzGerald …