Oral Bacterial Extract for Wheezing

(ORBEX Trial)

Recruiting at 10 trial locations

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Arizona

Must not be taking: Corticosteroids, Immunotherapy, Immunosuppressants, others

Disqualifiers: Asthma, Seizures, Cardiac disorder, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

822 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken inhaled or systemic corticosteroids for respiratory illness in the month before joining. It's best to discuss your current medications with the study team.

What data supports the effectiveness of the drug Broncho-Vaxom for wheezing?

Research shows that Broncho-Vaxom, a bacterial extract, can reduce airway inflammation and prevent allergic diseases in mice, and it has been effective in reducing symptoms in conditions like chronic bronchitis and sinusitis in humans. This suggests it might help with wheezing by boosting the immune system and reducing inflammation. ^{1 2 3 4 5}

How is the drug Broncho-Vaxom unique for treating wheezing?

Broncho-Vaxom is unique because it is an oral bacterial extract, which means it uses components from bacteria to help boost the immune system, unlike other treatments that might focus on directly targeting symptoms or allergens. This approach is different from typical medications that are often inhaled or injected and work by reducing inflammation or opening airways. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Dave T Mauger, PhD

Principal Investigator

Penn State University, Data Coordinating Center

Wayne J Morgan, MD

Principal Investigator

University of Arizona

Fernando D Martinez, MD

Principal Investigator

University of Arizona

Eligibility Criteria

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.

Inclusion Criteria

Adequate completion of informed consent process with written documentation. The participant's legally acceptable representative must have provided the appropriate written informed consent.

I have a parent/guardian who can talk to the study team in English or Spanish.

My child's guardian has a working phone.

Exclusion Criteria

Participants may not have been born earlier than 36 weeks of gestation.

You should not have experienced any severe lung infections in the past.

I have not been diagnosed with asthma by a doctor.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Broncho-Vaxom® or placebo for ten days each month for two consecutive years

24 months

Observation

Three-year observation period to monitor the time to occurrence of the first WLRI episode while off study drug

36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Broncho-Vaxom

Trial Overview 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.

Participant Groups

Group I: Broncho-Vaxom (BV) Active Control 1 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: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

References

1. China pubmed.ncbi.nlm.nih.gov

Protective effect of a bacterial extract against acute exacerbation in patients with chronic bronchitis accompanied by chronic obstructive pulmonary disease. [2012]

2. United States pubmed.ncbi.nlm.nih.gov

The oral administration of bacterial extracts prevents asthma via the recruitment of regulatory T cells to the airways. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Immunomodulation with bacterial extracts in respiratory diseases. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Clinical efficacy of Broncho-Vaxom in adult patients with chronic purulent sinusitis--a multi-centric, placebo-controlled, double-blind study. [2012]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Bacterial lysate increases the percentage of natural killer T cells in peripheral blood and alleviates asthma in children. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Lack of effect of Timothy grass pollen sublingual immunotherapy tablet on birch pollen-induced allergic rhinoconjunctivitis in an environmental exposure unit. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Further evaluation of local intranasal immunotherapy with aqueous and allergoid grass extracts. [2019]

8. Denmark pubmed.ncbi.nlm.nih.gov

Development and evaluation of a sublingual tablet based on recombinant Bet v 1 in birch pollen-allergic patients. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Clinical and immunological studies of timothy antigen D immunotherapy. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Development of transgenic rice expressing mite antigen for a new concept of immunotherapy. [2015]