GSK3772847 in participants with Asthma with AFAD
Research type
Research Study
Full title
A double blind (sponsor open) placebo-controlled, stratified, parallel group study to evaluate the efficacy and safety of repeat doses of GSK3772847 in participants with moderate to severe asthma with allergic fungal airway disease (AFAD).
IRAS ID
236091
Contact name
Andrew Wardlaw
Contact email
Sponsor organisation
GSK
Eudract number
2017-003544-20
Duration of Study in the UK
1 years, 2 months, 23 days
Research summary
GlaxoSmithKline (GSK) is conducting a study (207972) to investigate an experimental drug (GSK3772847) as a potential treatment for patients with moderate to severe asthma with Allergic Fungal Airways Disease (AFAD).
GSK3772847 is a new medicine given by injection and is not yet approved for doctors to treat patients with asthma. This study, funded by GSK, will test how safe and effective GSK3772847 is at treating and preventing worsening of asthma in patients with AFAD symptoms when given at the same time as standard treatment.This study will compare GSK3772847 to a placebo (a placebo looks like the study medicine but doesn’t contain the actual medicine) in eligible participants with moderate to severe asthma with AFAD. A computer will decide whether a participant will receive GSK3772847 or placebo. Participants and study doctors will not know which treatment the participant has been assigned to. Participants will continue taking their normal asthma medication throughout the study.
Eligible patients will be ≥18 years old with moderate to severe asthma with AFAD taking high doses of inhaled corticosteroids/long-acting beta-2-agonist combination (ICS/LABA). They will receive either GSK3772847 or placebo as an intravenous infusion (sent directly into the vein using a needle or tube) 3 times during the study. These treatment visits are 4-weeks apart and each infusion will last 30 minutes.Approximately 46 participants will take part in the study and will attend 8 hospital visits over the course of the study. There will be a screening period of up to 4 weeks followed by a 12-week treatment period and 12-week additional follow-up period (total 28 weeks duration). Various assessments will be performed during these visits including physical examinations, blood tests, health questionnaires, lung and heart tests.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
17/YH/0432
Date of REC Opinion
8 Feb 2018
REC opinion
Further Information Favourable Opinion