The ORBEX Trial for the Prevention of Asthma
The Oral Bacterial Extract (ORBEX) Study is a research study to investigate if Broncho-Vaxom® can help prevent or reduce the development of asthma. Broncho-Vaxom® has been given to over 43 million children since its introduction in the 1980s and has an excellent safety profile.
Asthma is the most common chronic disease seen in children, affecting roughly 10% of all children in the U.S. Even with proper management, it can be a life-threatening condition and it is the leading cause of missed school days and third leading cause of hospitalizations for children less than 15 years of age, according to the American Lung Association.
It is thought that being exposed to certain bacteria is important for the developing immune system and that modern lifestyles limits children’s exposures to these bacteria, leading to abnormal immune system development and asthma 1. Broncho-Vaxom® is a mixture of killed bacteria that stimulate the immune system2 and is commonly used in countries all over the world in the treatment and prevention of respiratory diseases. The FDA has not yet approved it for use in the United States.
Participation in the ORBEX trial occurs over the course of 3 years. For the first 2 years, children receive study medication mixed in their milk or water for 10 days out of each month. Children are followed for an additional 3rd year to gather data on any longer-term benefits. Total compensation for completion of this study is up to $1,760.
In order to participate in this trial, children must be less than 17 months old and have one or more of the following risk factors for asthma:
- A diagnosis of eczema or atopic dermatitis from their doctor
- A parent or sibling who has asthma
To learn more about the study, please visit the study’s main website at https://breatheeasyearly.info/.
If you are interested in being contacted by our study team about learning more or having your child participate in this trial, please complete our brief survey.
This research study has been approved by the Biomedical UNC-CH IRB: Study #18-1158. The Principal Investigators of this study at UNC are Drs. Stephanie Davis and Michelle Hernandez.
ClinicalTrials.gov Identifier: NCT02148796
1 Stein, M. M., Hrusch, C. L., Gozdz, J., Igartua, C., Pivniouk, V., Murray, S. E., . . . Sperling, A. I. (2016). Innate Immunity and Asthma Risk in Amish and Hutterite Farm Children. New England Journal of Medicine N Engl J Med, 375(5), 411-421. doi:10.1056/nejmoa1508749
2Yin, J. Baoping X, Xiantao Z, Shen K. (2018). Broncho-Vaxom in Pediatric Recurrent Respiratory Tract Infections: A Systematic Review and Meta-Analysis. International Immunopharamacology, 54(2018), 198-209. doi:10.1016/j.intimp.2017.10.032