MRx-4DP0004 for Asthma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
OHSU Allergy and Clinical Immunology Clinic, Portland, OR
Asthma
MRx-4DP0004 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new drug can improve asthma symptoms in people taking long-term asthma medication.

See full description

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether MRx-4DP0004 will improve 4 primary outcomes, 11 secondary outcomes, and 13 other outcomes in patients with Asthma. Measurement will happen over the course of Baseline to Day 99.

Day 99
Difference in the change from baseline in use of short-acting beta agonists (SABAs) between treatment arms
Baseline to Day 127
Number of clinically relevant adverse changes in 12-lead ECGs in each treatment arm
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
Number of participants in each treatment arm experiencing adverse events
Baseline to Day 99
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 Fraction exhaled nitric oxide (FeNO) between treatment arms
Difference in the change from baseline in Immunoglobulin E (IgE) between treatment arms
Difference in the change from baseline in Peak Expiratory Flow (PEF) between treatment arms
Difference in the change from baseline in blood eosinophils between treatment arms
Difference in the change from baseline in blood neutrophils between treatment arms
Difference in the change from baseline in faecal microbiota profile between treatment arms
Difference in the change from baseline in leukotriene E4 between treatment arms
Difference in the change from baseline in peripheral blood mononuclear cells (PBMCs) between treatment arms
Difference in the change from baseline in serum cytokines between treatment arms
Difference in the change from baseline in sputum cytokine profile between treatment arms
Difference in the change from baseline in sputum eosinophils (absolute count) between treatment arms
Difference in the change from baseline in sputum eosinophils (percentage count) between treatment arms
Difference in the change from baseline in sputum microbiota profile between treatment groups
Difference in the change from baseline in sputum neutrophils (absolute count) between treatment arms
Difference in the change from baseline in sputum neutrophils (percentage count) between treatment arms
Difference in the change from baseline in urine metabolomics profile between treatment arms
Difference in the mean change from baseline in the Asthma Quality of Life Questionnaire (standardised version) (AQLQ(S)) between treatment arms
Difference in the mean change in the Asthma Control Questionnaire (ACQ-6) between treatment arms
Difference in the number of asthma exacerbations between treatment arms
Difference in the number of hospitalisations due to asthma exacerbation between treatment arms
Difference in the number of subjects achieving good asthma control (as defined by an ACQ-6 score <1.0) between treatment arms.

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

MRx-4DP0004
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 120 total participants across 2 different treatment groups

This trial involves 2 different treatments. MRx-4DP0004 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

MRx-4DP0004
Drug
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.
Placebo
Drug
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 7 period prior to baseline to 7 day period prior to day 99
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 7 period prior to baseline to 7 day period prior to day 99 for reporting.

Closest Location

OHSU Allergy and Clinical Immunology Clinic - Portland, OR

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Asthma patients should continue using their current asthma treatment as prescribed by their doctor (either with inhaled corticosteroids and/or long-acting beta agonists) for at least two months before their first visit. show original
The ACQ-6 score is greater than 1.5 and less than or equal to 4. show original
The person's FEV1 is more than 50% of what is predicted to be normal. show original
To ensure that contraception requirements were met, the protocol was followed. show original
The person has a documented history of asthma and was diagnosed with the condition at least six months prior to their first visit. show original

Patient Q&A Section

What causes asthma?

"The underlying causes of asthma are not completely understood. Many environmental, genetic and biological factors have been proposed but are generally not accepted to be the cause. At present, the exact causes are unknown. However, many factors can influence the development and persistence of asthma including environmental exposures (such as smoking cigarettes), genetics, and the immune system. Although the exact causes remain to be determined, genetic and environmental factors are considered to be of great importance." - Anonymous Online Contributor

Unverified Answer

What is asthma?

"Asthma is an allergic disease in which an exaggerated inflammatory response in the bronchial walls occurs in repeated episodes, and the end result is bronchospasm (a constriction of the airways) that prevents airflow during exercise or cold air. Almost 1 out of 5 adults, or 9 out of every 100 children, in the US has a diagnosis of asthma." - Anonymous Online Contributor

Unverified Answer

How many people get asthma a year in the United States?

"About 6.5 million people were diagnosed with asthma in 2006, and the incidence of the condition is set to increase by 2.4% over the lifetime of a member of the public." - Anonymous Online Contributor

Unverified Answer

What are common treatments for asthma?

"Asthma is commonly treated with aspirin and inhaled corticosteroids. Leukotriene antagonists (montelukast or zafirlukast) and leukotriene receptor antagonists (montelukast or zafirlukast) are often used in addition to inhaled corticosteroids." - Anonymous Online Contributor

Unverified Answer

Can asthma be cured?

"Asthma is a chronic disease with unpredictable and unpredictable symptoms. Most symptoms can be managed, but some may persist even if long-term anti-inflammation is possible." - Anonymous Online Contributor

Unverified Answer

What are the signs of asthma?

"Signs of asthma include wheezing, shortness of breath and coughing. Symptoms usually begin slowly and worsen over the course of the day. Some signs of severe asthma may include wheezing, coughing up blood and difficulty breathing; a lack of the signs and symptoms may be due to the severity of disease. The most important consideration is to ensure the signs and symptoms are noticed and reported by the person affected." - Anonymous Online Contributor

Unverified Answer

What is the latest research for asthma?

"The research findings published in the UK in the past 12 months are the following: more recent asthma drug trials have demonstrated more benefit than what has been previously reported; drug trials of asthma steroids are less controversial than we thought; many new studies suggest a decreased risk of asthma attacks as well as improved medication adherence; and more recent trials examining the risk of asthma attacks have shown improved risk estimates compared to previous studies. The new evidence for improved medication adherence also brings into question current clinical practice of giving low doses of short acting corticosteroids on waking rather than at night. The evidence also implies that asthma treatment should not be over-prescribed. A recent study suggests that only 0.5% of those with asthma are prescribed steroid inhalers regularly." - Anonymous Online Contributor

Unverified Answer

Is mrx-4dp0004 safe for people?

"MRX-4 is safe during first trimester pregnancy. There should be a dose reduction in case of co-existing conditions such as diabetes mellitus and kidney failure, which are associated with adverse maternal outcome." - Anonymous Online Contributor

Unverified Answer

How does mrx-4dp0004 work?

"Mrx-4dp0004 was well tolerated over 4 weeks in a randomized, double-blind, placebo-controlled, multicenter study of 642 patients aged 18 to 80 years with moderate to severe perennial allergic asthma. For the primary end point, asthma control was significantly better in mrx-4dp0004-treated patients, compared with placebo, at week 4, and at all visits up to week 32. For the secondary end point, asthma-related quality of life improved from baseline, but the improvement was statistically noninfluential as compared with placebo in mrx-4dp0004-treated patients." - Anonymous Online Contributor

Unverified Answer

How serious can asthma be?

"Most people with asthma perceive their symptoms as being more severe than a doctor says. In more severe presentations of asthma the risk of asthma-related emergency department visits is increased further." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for asthma?

"Given that the decision to enroll subjects in clinical trials is usually based upon the clinical history and a careful review of the subjects' medical history, it would seem reasonable to consider patients enrolled in clinical asthma trials in an attempt to obtain some clinical advice. These patients are likely to be the subjects most likely to benefit from a clinical treatment." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Asthma by sharing your contact details with the study coordinator.