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Bacterial Lysate Vaccine

Multiple Interventions for Severe Asthma

Q: How many healthcare facilities are currently participating in this trial?

<p>Mount Sinai in <a href="https://www.withpower.com/clinical-trials/new-york">New york</a>, University of <a href="https://www.withpower.com/clinical-trials/california">California</a> San Francisco, and the University of <a href="https://www.withpower.com/clinical-trials/michigan">Michigan</a> Ann Arbor are three out of 32 different medical centres involved in this trial.</p>

Verified Trial

Phase 2

Recruiting

Led By Anastasia Ivanova

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Answer YES if you are NOT a current smoker and DO NOT have a significant smoking history (>10 years of smoking).

Have you had an asthma flare within the last year (i.e. placed on oral steroids)?

Timeline

Screening 1 months

Treatment 14 months

Follow Up 1 months

Awards & highlights

Study Summary

This trial is testing different interventions for severe asthma sufferers. Each person tries a different intervention for 16 weeks, followed by a break, then tries another one.

Who is the study for?

Adults and children over 12 with severe asthma, who've had a flare-up in the past year despite treatment, can join. They must have poor symptom control and not be current heavy smokers or have other major health issues like cancer or heart disease within the last five years.Check my eligibility

What is being tested?

The study tests multiple treatments for severe asthma: MCT, Cavosonstat, Imatinib Mesylate, Broncho-Vaxom, Clazakizumab against a placebo. Participants will switch between treatments every 16 weeks with breaks in between to clear their systems.See study design

What are the potential side effects?

Potential side effects may include irritation at the injection site, respiratory symptoms worsening temporarily after treatment starts, fatigue, headache and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not currently smoking and have not smoked significantly in the past.

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I have had an asthma attack that required oral steroids in the past year.

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I experience daily symptoms of asthma like coughing and shortness of breath.

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I have not had cancer, heart disease, autoimmune or lung diseases in the last 5 years.

Timeline

Screening ~ 1 months2 visits

Treatment ~ 14 months10 visits

Follow Up ~ 1 months2 visits

Screening ~ 1 months

Treatment ~ 14 months

Follow Up ~1 months

This trial's timeline: 1 months for screening, 14 months for treatment, and 1 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

CompEx events

Forced Expiratory Volume in one second (FEV1) percent predicted

The Juniper Asthma Control Questionnaire (ACQ-6)

Secondary outcome measures

Asthma free days

FEV1 post-bronchodilation

Forced Vital Capacity (FVC) pre-bronchodilation

+3 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: Medium Chain Triglycerides (MCT)Experimental Treatment2 Interventions

Participants in this arm will receive Medium Chain Triglycerides (MCT) powder packets (10 g each) at each treatment visit at any point in the study. Participants will mix 1-2 packets of MCT supplement powder into liquids or semi-solid food and ingest 3 times a day during the 16-week treatment period. Participants will be randomized to the treatment sequence and will receive either the active MCT or the matching placebo first or vice versa.

Group II: ImatinibExperimental Treatment2 Interventions

At any point in the study, participants randomized to this arm will take two 100 mg Imatinib tablets orally once a day with a meal and an 8 oz glass of water for 2 weeks. Participants will then take four 100 mg tablets once a day with a meal and an 8 oz glass of water for 14 weeks. Participants will be randomized to the treatment sequence and will receive either the active Imatinib or the matching placebo first or vice versa.

Group III: ClazakizumabExperimental Treatment2 Interventions

Participants randomized to this arm will receive a 12.5 mg dose of Clazakizumab via a subcutaneous injection at every study visit, every 4 weeks, during the 16-week treatment period at any point in the study. Participants will be randomized to the treatment sequence and will receive either the active Clazakizumab or the matching placebo first or vice versa.

Group IV: CavosonstatExperimental Treatment2 Interventions

Participants randomized to this arm will take one 50 mg Cavosonstat capsule orally twice a day for the 16-week treatment period duration at any point in the study. Participants will be randomized to the treatment sequence and will receive either the active Cavosonstat or the matching placebo first or vice versa.

Group V: Broncho-VaxomExperimental Treatment2 Interventions

Participants randomized to this arm will receive 7 mg of Broncho-Vaxom once a day on an empty stomach for the 16-week treatment period duration at any point in the study. Participants will be randomized to the treatment sequence and will receive either the active Broncho-Vaxom or the matching placebo first or vice versa.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MCT

2019

N/A

~210

Cavosonstat

2016

Completed Phase 2

~170

Imatinib Mesylate

2003

Completed Phase 4

~800

Broncho-Vaxom

2003

Completed Phase 3

~180

Clazakizumab

2012

Completed Phase 2

~170

0 / 6Eligibility criteria met

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,190,442 Total Patients Enrolled

30 Trials studying Asthma

1,621 Patients Enrolled for Asthma

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,837 Previous Clinical Trials

47,851,027 Total Patients Enrolled

276 Trials studying Asthma

111,951 Patients Enrolled for Asthma

Anastasia IvanovaPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Media Library

Broncho-Vaxom (Bacterial Lysate Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04129931 — Phase 2

Asthma Research Study Groups: Broncho-Vaxom, Cavosonstat, Medium Chain Triglycerides (MCT), Clazakizumab, Imatinib

Asthma Clinical Trial 2023: Broncho-Vaxom Highlights & Side Effects. Trial Name: NCT04129931 — Phase 2

Broncho-Vaxom (Bacterial Lysate Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04129931 — Phase 2

Asthma Patient Testimony for trial: Trial Name: NCT04129931 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many healthcare facilities are currently participating in this trial?

"Mount Sinai in New york, University of California San Francisco, and the University of Michigan Ann Arbor are three out of 32 different medical centres involved in this trial."

Answered by AI

Has there been any other research on the use of MCT?

"Presently, there are 63 active studies related to MCT. 19 of those clinical trials have advanced to the third phase and many sites in Samsun, Quebec are contributing research on this medical intervention. Globally, 1937 sites are conducting investigations into its efficacy."

Answered by AI

Is there a risk of harm associated with the usage of MCT in patients?

"MCT's safety has been established in Phase 2 trials, thus it was given a score of 2. As such, there is limited evidence to support the efficacy of this medication."

Answered by AI

Is enrollment still available for this research endeavor?

"Indeed, the clinical trial is currently enlisting participants. The listing on clinicaltrials.gov displays that it was first posted in December 19th 2019 and recently updated on August 9th 2022."

Answered by AI

What is the cohort size of this research venture?

"This clinical trial requires 600 suitable patients to be enrolled. Eligible candidates can join the study at Mount Sinai in New york or University of California San Francisco in San Francisco."

Answered by AI

How is MCT typically employed for medicinal purposes?

"Methylprednisolone is usually prescribed to those with newly diagnosed acute lymphoblastic leukaemia and can be successful in treating conditions such as refractory all, muscular dystrophy, and metastatic dermatofibrosarcoma protuberans."

Answered by AI