A first in human phase I/II study of MRx-4DP0004 in asthma
Research type
Research Study
Full title
A first in human, double-blind, placebo-controlled, multicentre Phase I/II study to evaluate the safety, tolerability and immune modulatory effects of MRx-4DP0004 (a lyophilised formulation of Bifidobacterium breve proprietary strain of 4D Pharma Research) in participants taking long-term control medication for their asthma\n
IRAS ID
256695
Contact name
Charlotte Pai
Contact email
Sponsor organisation
4D Pharma plc
Eudract number
2018-003242-16
Duration of Study in the UK
1 years, 8 months, 0 days
Research summary
Asthma is an airways disease characterised by inflammation and obstruction of the airways. The main aim of asthma treatment is to achieve and maintain asthma control. The first step is to use a drug known as a beta2 agonist; makes breathing easier by relaxing the muscles in the lungs. If asthma is not controlled on a beta2 agonist, a steroid inhaler is usually added to improve asthma control.\nDespite the current treatment options, many patients with asthma are still partly controlled and at risk of severe symptoms. The sponsor of the study (4D Pharma plc) has developed a product called MRx-4DP0004, which contains healthy bug (bacterium) called Bifidobacterium breve. This bacterium is naturally present in the human gut. MRx-4DP0004 has been shown in animals to improve markers of asthma. It is now considered appropriate to study MRx-4DP0004 in humans.\nThe purpose of this study is to examine the safety of MRx-4DP0004 in participants with asthma. MRx-4DP0004 will be added to the patients existing asthma treatment to determine if the control of the asthma can be further improved. \nParticipants will be assigned at random (like the flip of a coin) to one of the following study groups:\n1)\tMRx-4DP0004: two capsules twice daily\n2)\tPlacebo (dummy capsule that looks like the MRx-4DP0004 capsule but contains no B. breve): two capsules twice daily\n\nThis is a randomised, placebo controlled, double−blind study meaning neither the patient nor the study doctor will know which medication is being given. Participants will receive study medication for 14 weeks in total. There will be a two week period when participants will receive placebo, even if they are randomised to receive MRx-4DP0004. \nA total of 90 adult male and female participants aged 18 to 65 years with asthma are required at centres in the UK, Germany and Poland.\n
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
19/YH/0026
Date of REC Opinion
9 Apr 2019
REC opinion
Further Information Favourable Opinion