Multiple Interventions for Severe Asthma

Recruiting in Palo Alto (17 mi)

+31 other locations

Overseen byAnastasia Ivanova, PhD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of North Carolina, Chapel Hill

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing various treatments for severe asthma in people whose symptoms aren't controlled by standard medications. The treatments are customized based on individual patient characteristics to find the most effective approach.

Research Team

Anastasia Ivanova, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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.

Inclusion Criteria

I've needed a significant increase in my asthma medication at least once last year.

Have you been taking your current asthma medications for at least the last two months?

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

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Exclusion Criteria

I have a University of Michigan MRN# (Medical Record Number). If you receive care at a U of M provider, clinic, or hospital, you will have an MRN number.

Are you been taking your current asthma medications for at least the last two months?

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

See 28 more

Treatment Details

Interventions

Broncho-Vaxom (Bacterial Lysate Vaccine)
Cavosonstat (Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Corrector)
Clazakizumab (Monoclonal Antibody)
Imatinib Mesylate (Tyrosine Kinase Inhibitor)
Itacitinib (Janus Kinase (JAK) Inhibitor)
MCT (Drug)
Placebo (Other)

Trial OverviewThe 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.

Participant Groups

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.