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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

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

Awards & highlights

ORBEX Trial Summary

This trial evaluates if Broncho-Vaxom, given to high-risk infants monthly for two years, can prevent wheezing lower respiratory tract illness for three years after treatment.

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.Check my eligibility

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.See study design

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.

ORBEX Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My child's guardian has a working phone.

ORBEX Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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 outcome measures

Change in height and weight from baseline

Cumulative does of controller ICS

Cumulative systemic corticosteroid courses

+8 more

ORBEX 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor

514 Previous Clinical Trials

147,449 Total Patients Enrolled

1 Trials studying Wheezing

1,476 Patients Enrolled for Wheezing

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

Wheezing Research Study Groups: Broncho-Vaxom (BV), Placebo

Wheezing 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the requirements to qualify for this clinical trial?

"Asthmatic infants aged 6 to 18 months old are qualified to participate in this upcoming clinical trial. A total of 822 children will be accepted into the study."

Answered by AI

Are there numerous clinics running this clinical trial in the United States and Canada?

"Right now, there are 11 sites where you can enroll in this study. Some of these locations include Atlanta, Washington and Oakland. There are also 11 other places. If you decide to participate in this trial, try to choose the location that is closest to you so that travelling isn't too difficult."

Answered by AI

How many people are being recruited for this experiment?

"Unfortunately, this study is no longer taking candidates. The original posting was on 1/3/2017 and the last edit was 5/2/2022. However, there are presently 334 trials actively admitting participants with asthma and 4 studies for Broncho-Vaxom (BV) that are still enrolling patients."

Answered by AI

Does the age limit for participants end at 20 years old?

"The age limit for participants in this trial is between 6 and 18 months old."

Answered by AI

Are there any other notable instances where BV has been used in research?

"The original study for Broncho-Vaxom (BV) took place in 2017 at Boston Children's Hospital, Harvard University. So far there have been 18294 completed trials. There are currently 4 actively recruiting clinical trials, with a large number of these studies running out of Atlanta, Georgia."

Answered by AI

Is it risky to take Broncho-Vaxom (BV)?

"Since this is a Phase 2 trial, meaning that there is only evidence of safety and no efficacy, our team at Power has given Broncho-Vaxom (BV) a score of 2."

Answered by AI

Are there any more patient slots available for this research project?

"Unfortunately, this study is not currently looking for new patients as of May 2nd, 2022. According to the same source, this trial was first posted on January 3rd, 2017. There are 338 other trials that are still recruiting candidates."

Answered by AI

Recent research and studies

BMC PediatricsJournal

Respiratory Viral Infections in Children with Asthma: Do They Matter and Can We Prevent Them?

Ahanchian, Hamid, Carmen M Jones, Yueh-sheng Chen, and Peter D Sly. 2012. “Respiratory Viral Infections in Children with Asthma: Do They Matter and Can We Prevent Them?”. BMC Pediatrics. Springer Science and Business Media LLC. doi:10.1186/1471-2431-12-147.

BmjJournal

Probiotic Supplementation During Pregnancy or Infancy for the Prevention of Asthma and Wheeze: Systematic Review and Meta-analysis

Azad, M. B., J. G. Coneys, A. L. Kozyrskyj, C. J. Field, C. D. Ramsey, A. B. Becker, C. Friesen, A. M. Abou-Setta, and R. Zarychanski. 2013. “Probiotic Supplementation During Pregnancy or Infancy for the Prevention of Asthma and Wheeze: Systematic Review and Meta-analysis”. Bmj. BMJ. doi:10.1136/bmj.f6471.

Journal of Allergy and Clinical ImmunologyJournal

The Canadian Asthma Primary Prevention Study: Outcomes at 2 Years of Age

Becker, Allan, Wade Watson, Alexander Ferguson, Helen Dimich-Ward, and Moira Chan-Yeung. 2004. “The Canadian Asthma Primary Prevention Study: Outcomes at 2 Years of Age”. Journal of Allergy and Clinical Immunology. Elsevier BV. doi:10.1016/j.jaci.2004.01.754.

American Journal of Respiratory and Critical Care MedicineJournal