The primary objective of this study is to evaluate if Broncho-Vaxom® given to high risk infants for 10 days, monthly, for two consecutive years can increase time to occurrence of the first episode of wheezing lower respiratory tract illness (WLRI) during a three year observation period off therapy.
This is a five year parallel arm, double-blind, placebo-controlled trial for the prevention of WLRI into the third to seventh year of life (30 to 78 mo inclusive) in young children (6-18 months old) at increased risk for asthma. The trial will be divided into 2 periods. During the initial treatment period (first and second years in the study) participants will receive Broncho- Vaxom® (3.5 mg) or placebo for ten days each month for two consecutive years. This period will allow the observation of key secondary outcomes while participants are receiving therapy. The second period (third through fifth years in the study) will be a three year observation of the time to occurrence of the first WLRI episode (primary outcome) while off study drug along with the secondary outcomes noted above. During both the treatment and observation periods, participants will be managed by study physicians using a rescue algorithm applied in the PEAK trial commensurate with the NAEPP Expert Panel Report (EPR) III guidelines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
822
Active Ingredient: Lyophilised bacterial extract; Chemical Name: OM-85 BV; Strength: 3.5 mg; Excipients: bacterial extract, propyl gallate, sodium glutamate, mannitol, pregelatinised starch, magnesium stearate; Appearance: Blue and white capsule; Dosage Form: 3.5 mg capsule; Manufacturer: OM Pharma, Switzerland (OM stands for Omnia Medicamenta) Storage: Store in the original package
A placebo capsule will be used that will be indistinguishable from the active study drug.
Phoenix Children's Hospital
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
University of California San Francisco, Benioff Children's Hospital
Oakland, California, United States
The time to the occurrence of the first WLRI episode in the observation period while not receiving study drug
The time to the occurrence of the first WLRI episode in the observation period while not receiving study drug
Time frame: ages 30 to 42 months at the end of treatment; ages 66 to 78 months at completion
The time to first WLRI during the two treatment years while receiving study drug
The time to first WLRI during the two treatment years while receiving study drug
Time frame: ages 6 to 18 months at start of therapy; ages 30 to 42 months at completion
The annualized rate of WLRI episodes during the two years while receiving study drug
The annualized rate of WLRI episodes during the two years while receiving study drug
Time frame: ages 6 to 18 months at start of therapy; ages 30 to 42 months at completion
The annualized rate of WLRI episodes during the observation period while not receiving study drug
The annualized rate of WLRI episodes during the observation period while not receiving study drug
Time frame: ages 30 to 42 months at the end of treatment; ages 66 to 78 months at completion
The annualized rate of severe wheezing respiratory tract illness (SWLRI) episodes during the two treatment years while receiving study drug.
SWLRI episodes are defined as cough and wheezing \> 24 hours AND any one of the following: * Use of more than 6 albuterol treatments in ≤48 hours. * Unscheduled care visit for acute wheezing in doctor's office, urgent care or emergency department -or- hospitalization for wheezing. * Use of systemic corticosteroid prescribed by a licensed medical provider for a wheezing illness with or without a clinical visit. * The annualized rate of SWLRI episodes during the two years while receiving study drug.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Children's National Health System
Washington D.C., District of Columbia, United States
Emory University
Atlanta, Georgia, United States
Boston Children's Hospital, Harvard University
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
Columbia University
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital & Medical Center
Cincinnati, Ohio, United States
...and 1 more locations
Time frame: ages 6 to 18 months at start of therapy; ages 30 to 42 months at completion
The annualized rate of severe wheezing respiratory tract illness (SWLRI) episodes during the observation period while not receiving study drug.
The annualized rate of severe wheezing respiratory tract illness (SWLRI) episodes during the observation period while not receiving study drug.
Time frame: ages 30 to 42 months at the end of treatment; ages 66 to 78 months at completion
Asthma at the end of the observation period
Asthma at the end of the observation period defined by any of the following three elements: (a) a health care provider diagnosis of asthma with reports of: at least one episode of wheezing or asthma in the previous year or asthma controllers prescribed for at least 6 months during the previous year; or (b) \>3 episodes of wheezing during the previous year 38 ("frequent wheezers"); or (c) any wheezing during the third observation year in children who wheezed during the first three years of life ("persistent wheezers").
Time frame: ages 30 to 42 months at the end of treatment; ages 66 to 78 months at completion
Safety and tolerability of Broncho-Vaxom® while receiving study drug during the two year treatment period.
Safety and tolerability of Broncho-Vaxom® while receiving study drug during the two year treatment period
Time frame: ages 6 to 18 months at start of therapy; ages 30 to 42 months at completion
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 observation period, after study drug has been stopped.
Time frame: ages 30 to 42 months at the end of treatment; ages 66 to 78 months at completion