PGx7612: Pharmacogenetic investigation of the association of the ADRB2 rare variant, Thr164Ile with severe asthma exacerbation (204661)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Pharmacogenetic study
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective, non-interventional exploratory genetic investigation study

Study drug and medical condition

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

  VILANTEROL TRIFENATATE
• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  Non-Hispanic white (NHW) subjects from HUI 06837 , ADA109055, and ADAI 09057 who were actually treated with Fluticasone Furoate/Vilanterol (GW685698 GW642444) in HZAI 06837 or Fluticasone Propionate/Salmeterol (GR33343+CC118781) in ADA109055 and ADA109057 and for whom the requisite genetic and clinical data were available.
• 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:
  876

Study design details

• Main study objective:
  Determine if there is evidence for the association of ADRB2 Thr164Ile with clinically significant asthma exacerbation in non-Hispanic white subjects treated with LABA.
• Outcomes:
  Clinically significant asthma exacerbations are defined as the requirement of treatment with an oral or parenteral corticosteroid or an unscheduled urgent care visit (e.g. unscheduled clinic visit, physician office visit, ED visit, hospitalization) for acute asthma symptoms requiring intervention.
• Data analysis plan:
  Retrospective analyses to test for an effect of the ADRB2 Thr164Ile genotype on asthma exacerbation rate in subjects treated with LABA-containing products.

Documents

Study results

gsk-204661-clinical-study-result-summary