Last updated: 04/04/2025 12:00:44
PGx7684: Confirmatory pharmacogenetic study investigating IL13 association with efficacy response to fluticasone furoate/vilanterol in asthma study 201378
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: PGx7684: Confirmatory pharmacogenetic study investigating IL13 association with efficacy response to fluticasone furoate/vilanterol in asthma study 201378
Trial description: Confirmatory pharmacogenetic evaluation using clinical data from study 201378 of one SNP, rs2243204, and flanking variants in the IL13 gene region that was associated with the FF/VI; GW685698/GW642444; Relvar® Ellipta® efficacy endpoint of change from Baseline in trough forced expiratory volume in one second (FEV1) at the end of study treatment period as identified in the completed PGx7659 study (Study ID 206822). PGx7659 utilized clinical data from asthma studies 106827, 106829, 106837, 113091 and 116863. RELVAR and ELLIPTA are trademarks of the GSK Group of Companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Change from Baseline in clinic visit evening (PM) FEV1 (pre-bronchodilator and pre-dose)
Timeframe: Study treatment period, i.e., treatment initiation to last dose: 24 weeks
Secondary outcomes:
Not applicable
Interventions:
Drug: Fluticasone furoate/vilanterol
Enrollment:
0
Observational study model:
Cohort
Primary completion date:
2017-16-06
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Asthma
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
June 2017 to June 2017
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
none
- Subjects who provided written informed consent and a deoxyribonucleic acid (DNA) sample and had clinical outcome data available were included in the study.
- Subjects who did not provide written informed consent, a DNA sample, or did not have the clinical outcome data available were excluded from study.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who provided written informed consent and a deoxyribonucleic acid (DNA) sample and had clinical outcome data available were included in the study.
Exclusion criteria:
- Subjects who did not provide written informed consent, a DNA sample, or did not have the clinical outcome data available were excluded from study.
Trial location(s)
No location data available.
Study documents
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2017-16-06
Actual study completion date
2017-16-06
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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