What is the mechanism of action of this treatment?

Common treatments for wheezing, especially those similar to Broncho-Vaxom®, include immunostimulants that aim to enhance the body's immune response. Broncho-Vaxom® works by exposing the immune system to bacterial extracts, which helps to 'train' the immune system to respond more effectively to respiratory pathogens. This can reduce the frequency and severity of wheezing episodes by preventing infections that often trigger these symptoms. For wheezing patients, this is crucial as it can lead to fewer respiratory infections, improved breathing, and a better overall quality of life.

What side effects are associated with this type of intervention?

Common treatments for wheezing, particularly immunostimulants like Broncho-Vaxom®, generally aim to enhance the immune response to reduce respiratory infections. Known side effects of such treatments can include gastrointestinal disturbances (e.g., nausea, vomiting, diarrhea), skin reactions (e.g., rash, itching), and, less commonly, respiratory symptoms like cough or nasal congestion. These side effects are typically mild and transient. It is important to consult with a healthcare provider to monitor and manage any adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for wheezing, particularly in the context of asthma management. Immunostimulants like Broncho-Vaxom® are designed to enhance the immune response and have been studied for their potential to prevent wheezing lower respiratory tract illnesses. Other related FDA-approved treatments include monoclonal antibodies such as omalizumab, which targets IgE to reduce allergic responses, and biologics like mepolizumab and reslizumab, which target eosinophilic inflammation. These therapies aim to reduce the frequency and severity of wheezing episodes in patients with asthma.

What other types of research exist?

Promising novel alternatives to Broncho-Vaxom® for wheezing patients include: 1) Omalizumab, an anti-IgE antibody, which has shown efficacy in facilitating rapid oral desensitization in high-risk allergic patients. 2) Dupilumab, an IL-4/IL-13 inhibitor, which has demonstrated efficacy in treating eosinophilic esophagitis and asthma. 3) Probiotic and peanut oral immunotherapy, which has shown long-term clinical and immunological benefits in allergic patients. These alternatives have shown potential in recent clinical trials and may offer new avenues for treatment in 2024.

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Bacterial Extract

Oral Bacterial Extract for Wheezing (ORBEX Trial)

Phase 2

Waitlist Available

Led By Fernando D Martinez, MD

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

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

Must have

The child's parent/guardian must have a working direct contact telephone.

Be younger than 18 years old

Must not have

Participants may not have a systemic illness (other than allergy) including (but not limited to) recurrent seizures, chronic gastroesophageal reflux (GER) requiring medical treatment, major congenital anomalies, physical and intellectual delay, cerebral palsy, chest surgery, tuberculosis or other chronic infections, primary or secondary immunodeficiency, gastrointestinal malformation or disease or cardiac disorder (except a hemodynamically insignificant atrial septal defect (ASD), ventricular septal defect (VSD) or benign heart murmur).

Participants may not have any other chronic lung disease; e.g. chronic lung disease of prematurity (CLDP) or cystic fibrosis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ages 30 to 42 months at the end of treatment; ages 66 to 78 months at completion

Summary

This trial tests if giving Broncho-Vaxom® to high-risk infants can delay their first episode of wheezing illness. The medication is given regularly over a long period and aims to boost the immune system. The study focuses on infants aged 6-18 months who are more likely to develop asthma.

Who is the study for?

This trial is for infants aged 6-18 months at high risk of wheezing illnesses and asthma, due to a family history of asthma, eczema, or sibling with asthma. They must not have had more than two prior WLRI episodes or certain treatments like steroids and immunotherapy. The child's family should be able to communicate in English/Spanish and stay in the study area for 3 years.

What is being tested?

The trial tests if Broncho-Vaxom (BV), given monthly for two years to high-risk infants, can delay the first episode of wheezing lower respiratory tract illness over three years without treatment. Infants will either receive BV or a placebo.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include allergic reactions to ingredients in Broncho-Vaxom or Placebo. Parents will monitor their children closely for any adverse signs that could relate to the oral bacterial extract.

Eligibility Criteria

Inclusion Criteria

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

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My child's guardian has a working phone.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any major chronic illnesses or conditions besides allergies.

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I do not have any chronic lung diseases like CLDP or cystic fibrosis.

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I haven't used corticosteroids for breathing issues or any condition in the last month.

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I have never received immunotherapy.

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I currently have an infection, even if it's being treated.

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I have never received intravenous immunoglobulins or systemic immunosuppressants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ages 30 to 42 months at the end of treatment; ages 66 to 78 months at completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~ages 30 to 42 months at the end of treatment; ages 66 to 78 months at completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and ages 30 to 42 months at the end of treatment; ages 66 to 78 months at completion for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The time to the occurrence of the first WLRI episode in the observation period while not receiving study drug

Secondary study objectives

Asthma at the end of the observation period

Safety and tolerability of Broncho-Vaxom® while receiving study drug during the observation period.

Safety and tolerability of Broncho-Vaxom® while receiving study drug during the two year treatment period.

+5 more

Other study objectives

Change in height and weight from baseline

Cumulative does of controller ICS

Cumulative systemic corticosteroid courses

+8 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Broncho-Vaxom (BV)Active Control1 Intervention

One capsule of Broncho-Vaxom for children contains: 3.5 mg of lyophilized bacterial lysates of Haemophilus influenzae, Streptococcus (pneumonia, pyogenes and sanguinis (viridans)), Klebsiella (pneumoniae and ozaenae), Staphylococcus aureus and Moraxella catarrhalis. The content of the capsule will be mixed with a palatable liquid such as fruit juice.

Group II: PlaceboPlacebo Group1 Intervention

A placebo capsule will be used that will be indistinguishable from the active study drug.

0 / 7Eligibility 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

Common treatments for wheezing, especially those similar to Broncho-Vaxom®, include immunostimulants that aim to enhance the body's immune response. Broncho-Vaxom® works by exposing the immune system to bacterial extracts, which helps to 'train' the immune system to respond more effectively to respiratory pathogens. This can reduce the frequency and severity of wheezing episodes by preventing infections that often trigger these symptoms. For wheezing patients, this is crucial as it can lead to fewer respiratory infections, improved breathing, and a better overall quality of life.