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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/42099
• EU PAS number:
  EUPAS10464
• Study ID:
  42099
• Official title and acronym:
  PGx7612: Pharmacogenetic investigation of the association of the ADRB2 rare variant, Thr164Ile with severe asthma exacerbation (204661)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  A recent publication (Lancet Respiratory Medicine 2014, 2:204-213) described evidence of association between a genetic variant, Thr164Ile, in the ADRB2 gene with hospitalization due to asthma exacerbations in non-Hispanic white patients treated with long-acting beta agonists (LABAs). Insufficient numbers of hospitalization events are documented among LABA-treated patients in GSK clinical studies to attempt a direct replication of this paper's findings. However, to better understand risk / benefit for our LABA-treatment regimes, we plan to explore the effect of this genetic variant (ADRB2 Thr164Ile) on the related endpoint evaluated in GSK clinical studies, clinically significant asthma exacerbations. The sample for this study will comprise genetic samples with relevant clinical data from patients enrolled in the studies HZA106837, ADA109055, and ADA109057.
• Study status:
  Finalised

Research institutions and networks

Institutions

GlaxoSmithKline (GSK)

Study timelines

Date when funding contract was signed

Planned: 04/05/2015

Actual: 04/05/2015

Study start date

Planned: 29/05/2015

Actual: 13/07/2015

Data analysis start date

Planned: 29/05/2015

Actual: 13/07/2015

Date of final study report

Planned: 17/03/2016

Actual: 22/02/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

gsk-204661-reporting-and-analysis-plan-redact

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable