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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 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.

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.

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
534 Previous Clinical Trials
158,712 Total Patients Enrolled
9 Trials studying Asthma
2,760 Patients Enrolled for Asthma
Wayne J Morgan, MDStudy DirectorUniversity of Arizona
1 Previous Clinical Trials
32 Total Patients Enrolled
Dave T Mauger, PhDStudy DirectorPenn State University, Data Coordinating Center

Media Library

Broncho-Vaxom (Bacterial Extract) Clinical Trial Eligibility Overview. Trial Name: NCT02148796 — Phase 2
Asthma Research Study Groups: Broncho-Vaxom (BV), Placebo
Asthma Clinical Trial 2023: Broncho-Vaxom Highlights & Side Effects. Trial Name: NCT02148796 — Phase 2
Broncho-Vaxom (Bacterial Extract) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02148796 — Phase 2
~100 spots leftby Dec 2025