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.
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.
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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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Riley Hospital for ChildrenIndianapolis, IN
University of MichiganAnn Arbor, MI
Boston Children's HospitalBoston, MA
Yale UniversityNew Haven, CT
More Trial Locations
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Who Is Running the Clinical Trial?
University of North Carolina, Chapel HillLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator