Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
34 participants
INTERVENTIONAL
2019-07-04
2023-04-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
NCT06977581
A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma.
NCT05763121
A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of AZD9898
NCT03140072
Phase II Study to Evaluate the Effect of AZD4604 on Airway Inflammation and Biomarkers in Adults With Asthma
NCT06435273
A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Eosinophilic Asthma
NCT05748600
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MRx-4DP0004
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.
MRx-4DP0004
Participants randomised to receive MRx-4DP0004 will take it in addition to their regular asthma medication.
Placebo
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.
Placebo
Participants randomised to receive placebo will take it in addition to their regular asthma medication.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MRx-4DP0004
Participants randomised to receive MRx-4DP0004 will take it in addition to their regular asthma medication.
Placebo
Participants randomised to receive placebo will take it in addition to their regular asthma medication.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Stable current asthma treatment as per GINA steps 2-4 (ICS with or without LABA) for at least 2 months prior to Visit 1.
* ACQ-6 score \>1.5 and \<=4
* FEV1 \>50% of predicted normal
* Following protocol specified contraception requirements.
Exclusion Criteria
* At significant risk of exposure to a change in environmental sensitising substances during the study.
* Co-morbidities not optimally controlled for the last 3 months or any co-morbidity that may put the subject at risk or influence the outcome of the study.
* Hepatitis B or C or HIV.
* GI fistula, feeding tubes or inflammatory bowel disease.
* GI disease resulting in inability for oral intake, malabsorption syndrome, surgical procedures affecting absorption, uncontrolled inflammatory bowel disease.
* History of life-threatening asthma.
* Systemic corticosteroids within 6 weeks of first dose.
* Allergy to all of ampicillin, clindamycin and imipenem.
* Probiotic supplements.
* Immunosuppression or immunosuppressant medication.
* Use of ICS and LABA as Maintenance and Reliever Therapy.
* Smokers or nicotine users within 3 months of screening.
* Former smokers \>15 pack years.
* Systemic antibiotics within 6 weeks of first dose.
* Clinically significant haematology and serum biochemistry.
* Sensitivity to any constituent of IMP.
* Diastolic blood pressure \<45 or \>90, systolic blood pressure \<95 or \>155mmHg, Pulse rate \<40 or \>100 bpm.
* Clinically significant ECGs or structural cardiac abnormalities.
* Any other condition that may interfere with primary objective.
* Receipt of a positive COVID-19 test result within 4 weeks of first dose of IMP
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
4D pharma plc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christopher Brightling, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Leicester
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
OHSU Allergy and Clinical Immunology Clinic
Portland, Oregon, United States
Bradford Teaching Hospital
Bradford, West Yorkshire, United Kingdom
4D Site Leicester
Leicester, , United Kingdom
4D Site Manchester
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MRx-4DP0004-I-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.