Effects of dupilumab on airway inflammation in adults with asthma
Research type
Research Study
Full title
An exploratory, randomised, double-blind, placebo-controlled study of the effects of dupilumab on airway inflammation of adults with persistent asthma - Liberty Asthma Expedition study
IRAS ID
188838
Contact name
Anita Pichori
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Developpemente
Eudract number
2015-001572-22
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
This study looks at the effect of a study drug (called dupilumab) on airway inflammation in people who have moderate to severe asthma. Dupilumab will be compared to a dummy drug (or ‘placebo’), and both treatments will be given by an injection every two weeks for twelve weeks. These injections are given on top of a person’s usual asthma treatment. Dupilumab is not yet licensed for asthma but it has been used in clinical trials to treat >1000 subjects with asthma or other conditions.
The study is made up of screening (3 to 5 weeks), treatment (12 weeks) and follow up periods (12 weeks).
At screening, subjects sign an informed consent form then they undergo various tests to see if they can go into the study. This will be followed by a visit to hospital to have a bronchoscopy procedure. This allows the doctor to look at the subject’s airway through a thin tube and take samples.
It will then be decided by chance which treatment the subject will receive: dupilumab or placebo. There is a 1 in 2 chance that subjects will receive dupilumab.
During the treatment period, subjects will come to clinic fortnightly for tests then dupilumab/placebo injections. Between clinic visits, subjects will complete an electronic diary and carry out a breathing test in the morning and evening daily at home. Subjects will be continually monitored and their dupilumab/placebo treatment stopped if they are unable to tolerate any side effects.
At the end of treatment, subjects will have another bronchoscopy. During follow up, subjects will be asked to come to clinic for more tests.
Subjects who have managed to take most or all of the dupilumab/placebo may be able to take part in a separate study in which everyone receives dupilumab for up to two years.REC name
South Central - Oxford C Research Ethics Committee
REC reference
15/SC/0616
Date of REC Opinion
3 Dec 2015
REC opinion
Further Information Favourable Opinion