The Emory Asthma Research team works to provide resources to asthma patients and families in the form of research study drugs, investigational studies, and asthma action plans. The ultimate goal of our efforts is to find the most innovative and effective treatment plans for those affected by asthma while pursuing the possibility of preventing asthma in high-risk children.

***For information on participating in any study, please contact Alice Bruce***

Oral Bacterial Extract for the Prevention of Wheezing Lower Respiratory Tract Illnesses (ORBEX) ​: ORBEX is a research study to see if early intervention with a bacterial extract called Broncho-Vaxom® will help prevent wheezing episodes in infants who are considered at high risk for asthma.

Your child may qualify if they are 5 - 16 months old and:

  • have a parent or older brother/sister with a history of asthma, or
  • have been diagnosed with atopic dermatitis (eczema)

Background

Asthma affects over 6 million children in the United States (U.S.) and the prevalence continues to increase. Wheezing Lower Respiratory Illnesses (WLRI) are the most common cause of hospitalization during early life and play a critical role in the later development of asthma.

Although there are effective treatments for established asthma, currently there are no marketed drugs in the U.S. that prevent the development of WLRI in young children or of asthma in later childhood.

ORBEX Study Details

Study design

  • 36 month parallel arm, double-blind, placebo-controlled trial for the prevention of WLRI into the third to fifth year of life (30 to 54 month inclusive) in young children (6-18 months old) at increased risk for asthma
  • Initial treatment period (1st and 2nd year in the study) - Participants will receive Broncho-Vaxom or placebo for ten days each month for two consecutive years
  • Second period (3rd year in the study) - One year observation of the time to occurrence of the first WLRI episode while off the study drug or placebo

Treatment

  • Infants will be randomized at 6-18 months of age in a 1:1 ration to receive either Broncho-Vaxom or placebo for 10 days each month for 24 months
  • Participants will take the first dose of each 10-day dosing period on the same day of the month, each month, and not before
  • The powdered contents of the capsule are mixed with a liquid, such as milk and given orally

Participants will be evaluated in the research clinic at time of enrollment, randomization, and at one and four months after receiving the study drug.

  • Will continue to be seen in clinic at 4 month intervals throughout duration of study
  • Monthly phone calls will be conducted to provide reminders and evaluate safety
  • Weekly texts will ask parents if their child had any breathing problems in the prior week

Dr. Fernando Martinez of The University of Arizona explains why he is passionate about the ORBEX Trial:

Clinical Research Principal Investigators and Co-Investigators                  

Dr. Anne Fitzpatrick                                                     

Dr. Jocelyn Grunwell                                              

Dr. Sheel Shah

 

Clinical Research Coordinators

Alice Bruce, BS, CCRP, CRC III

Shannon Kilman, BA, CRC I

Please click here for publications:

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