What side effects are associated with this type of intervention?

Common treatments for asthma include inhaled corticosteroids (ICS), which can cause side effects like oral thrush, hoarseness, and, rarely, systemic effects such as adrenal suppression. Long-acting beta-agonists (LABA) may lead to side effects like tremors, palpitations, and muscle cramps. Combination therapies (ICS/LABA) share these side effects but are generally well-tolerated. Leukotriene modifiers can cause headaches, gastrointestinal disturbances, and, in rare cases, neuropsychiatric events. Newer biologic treatments, such as monoclonal antibodies, may cause injection site reactions, headaches, and an increased risk of infections.

What prior FDA approvals exist?

The FDA has approved several treatments for asthma that are similar to those being studied in the 'Multiple Interventions' trial. These include combination inhalers containing inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA), such as fluticasone/salmeterol (Advair) and budesonide/formoterol (Symbicort). Additionally, the combination of ICS, LABA, and long-acting muscarinic antagonists (LAMA) like fluticasone/umeclidinium/vilanterol (Trelegy Ellipta) has also been approved. These treatments aim to reduce inflammation, relax airway muscles, and improve lung function in patients with asthma.

What other types of research exist?

Promising novel alternatives for asthma treatment in 2024 include biologics targeting specific pathways involved in asthma. These include IL-5 inhibitors (e.g., mepolizumab, reslizumab), IL-4/IL-13 inhibitors (e.g., dupilumab), and IL-17 inhibitors (e.g., secukinumab, ixekizumab). Additionally, bronchial thermoplasty, a non-pharmacologic intervention, remains a viable option for severe asthma. These treatments offer targeted approaches that can be more effective for patients with specific asthma phenotypes.

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Bacterial Lysate Vaccine

Multiple Interventions for Severe Asthma

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 month

Treatment 14 months

Follow Up 1 month

Summary

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.

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.

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.

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

Select...

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

Select...

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

Select...

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

Select...

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

Timeline

Screening ~ 1 month2 visits

Treatment ~ 14 months10 visits

Follow Up ~ 1 month2 visits

Screening ~ 1 month

Treatment ~ 14 months

Follow Up ~1 month

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CompEx events

Forced Expiratory Volume in one second (FEV1) percent predicted

The Juniper Asthma Control Questionnaire (ACQ-6)

Secondary study objectives

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

~180

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Inhaled corticosteroids (ICS) reduce inflammation in the airways, decreasing the frequency and severity of asthma attacks. Long-acting beta agonists (LABA) relax the smooth muscles around the airways, helping to keep them open for an extended period. Long-acting muscarinic antagonists (LAMA) block the action of acetylcholine on muscarinic receptors, preventing bronchoconstriction. These treatments are crucial for asthma patients as they address different aspects of the disease, improving lung function, reducing symptoms, and preventing exacerbations.