Status:
TERMINATED
A Study of MRx-4DP0004 in Asthma
Lead Sponsor:
4D pharma plc
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a multicentre, phase I/II, double-blind, placebo-controlled study of MRx-4DP0004 in participants taking long-term medication for asthma. Participants will take two capsules of MRx-4DP0004 twic...
Eligibility Criteria
Inclusion
- 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.
- ACQ-6 score \>1.5 and \<=4
- FEV1 \>50% of predicted normal
- Following protocol specified contraception requirements.
Exclusion
- Non-compliant with prescribed asthma maintenance treatment.
- 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
Key Trial Info
Start Date :
July 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2023
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03851250
Start Date
July 4 2019
End Date
April 26 2023
Last Update
April 17 2024
Active Locations (4)
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1
OHSU Allergy and Clinical Immunology Clinic
Portland, Oregon, United States, 97239
2
Bradford Teaching Hospital
Bradford, West Yorkshire, United Kingdom
3
4D Site Leicester
Leicester, United Kingdom
4
4D Site Manchester
Manchester, United Kingdom