*Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients with Asthma
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo controlled Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Patients with Uncontrolled Moderate to Severe Asthma
IRAS ID
1004110
Contact name
Caroline Leboul
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2021-003903-16
Clinicaltrials.gov Identifier
Research summary
The study is a placebo-controlled multinational study, aiming to enrol 1828 patients to complete the study.
Participants will be patients with uncontrolled moderate to severe Asthma, and will be approached to participate in the study by NHS clinical research teams (including doctors who specialise in treating asthma). Asthma is a chronic condition that if not well-controlled, can lead to poor lung function, severe breathing difficulties, and reduce quality of life over time. Therefore, one of the treatment goals of this condition is to prevent lung function from getting worse to improve overall quality of life.
The purpose of the study is to learn more about dupilumab (the study drug) when given over a longer duration (3 years) in patients with moderate to severe asthma that is not well controlled. The study will investigate if the study drug can prevent loss in lung function and improve asthma symptoms and quality of life by looking at whether the study drug works when taken for a longer period of time.
Participation will involve 16 on-site visits over more than 3 years, assessments include respiratory assessments and questionnaires. Participants will be randomly assigned by chance to receive either the study drug or a placebo, but neither participants nor the study doctor or nurses treating them will know which study medication they are receiving.
This study is sponsored by Sanofi-Aventis Recherche & Développement who are represented in the UK by Aventis Pharma Ltd, trading as Sanofi.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
22/EM/0179
Date of REC Opinion
23 Dec 2021
REC opinion
Further Information Favourable Opinion