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MRx-4DP0004 for Asthma
Phase 1 & 2
Waitlist Available
Led By Christopher Brightling, Professor
Research Sponsored by 4D pharma plc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented history and diagnosis of asthma at least 6 months prior to Visit 1.
Stable current asthma treatment as per GINA steps 2-4 (ICS with or without LABA) for at least 2 months prior to Visit 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 period prior to baseline to 7 day period prior to day 99
Awards & highlights
Study Summary
This study is evaluating whether a new drug can improve asthma symptoms in people taking long-term asthma medication.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 period prior to baseline to 7 day period prior to day 99
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 period prior to baseline to 7 day period prior to day 99
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Electrocardiogram
Number of clinically relevant adverse changes in clinical laboratory tests in each treatment arm
Number of clinically relevant adverse changes in vital signs in each treatment arm
+1 moreSecondary outcome measures
Difference in the change from baseline in Forced Expiratory Volume in 1 second (FEV1) between treatment arms
Difference in the change from baseline in Forced Vital Capacity (FVC) between treatment arms
Difference in the change from baseline in Peak Expiratory Flow (PEF) between treatment arms
+8 moreOther outcome measures
Nitric oxide
Difference in the change from baseline in Immunoglobulin E (IgE) between treatment arms
Difference in the change from baseline in faecal microbiota profile between treatment arms
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MRx-4DP0004Experimental Treatment1 Intervention
MRx-4DP0004 is a Live Biotherapeutic Product containing 10^9 to 10^10 Colony Forming Units.
Participants randomised to this arm will take 2 capsules twice daily at approximately 12 hour intervals for 12 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants randomised to this arm will take 2 capsules of placebo twice daily at approximately 12 hour intervals for 12 weeks.
All participants will receive placebo in a single blind manner for two weeks in addition to the 12 weeks of double blind treatment.
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Who is running the clinical trial?
4D pharma plcLead Sponsor
8 Previous Clinical Trials
580 Total Patients Enrolled
Christopher Brightling, ProfessorPrincipal InvestigatorUniversity of Leicester
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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