Effect of Dupilumab on Excerise Capacity in Patients with Asthma
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Dupilumab on Exercise Capacity in Patients with Moderate-to-Severe Asthma
IRAS ID
278440
Contact name
Sukh Dave Singh
Contact email
Sponsor organisation
Regeneron Pharmaceuticals Inc.
Eudract number
2019-002742-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 5 days
Research summary
Asthma is a condition in which the airways narrow, swell and produce extra mucus. This can make it difficult to breath and trigger coughing, wheezing and shortness of breath. Dupilumab is a type of drug called a “monoclonal antibody”. An antibody is a special kind of protein that the immune (defense) system normally makes to fight bacteria and viruses. Dupilumab has specifically been shown to block the action of the specific proteins called Interleukin 4 (IL-4) and Interleukin 13 (IL-13) which are thought to be involved in the development of inflammatory allergic diseases such as asthma. Dupilumab has been shown to increase lung function and improve asthma control. Dupilumab is being studied to see if it can improve how long an asthmatic can exercise for and physical activity. Dupilumab is an investigational drug in this study, because it has not been approved by any health authority to improve physical activity in patients with asthma.
This phase 4, randomised, placebo-controlled study is designed to see if treatment with the study drug increases exercise endurance time evaluated with a CWRET. CWRET is a constant work rate exercise test. This is an adult study open to men and women aged 18 to 55 with moderate to severe asthma. There will be approximately 140 patients worldwide. The study is randomised and double-blinded which means when a patient is enrolled they will be randomly selected for either the study drug dupilumab or the placebo. No one will know which group he or she will be in including the research team at site. This is to ensure there is no bias on the data collected. The patient will participate in the study up to 22 weeks.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
20/NW/0378
Date of REC Opinion
20 Nov 2020
REC opinion
Further Information Favourable Opinion