Oral Bacterial Extract for the Prevention of Wheezing Lower Respiratory Tract Illness (NCT02148796) | Clinical Trial Compass
CompletedPhase 2
Oral Bacterial Extract for the Prevention of Wheezing Lower Respiratory Tract Illness
United States822 participantsStarted 2017-01-01
Plain-language summary
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.
Who can participate
Age range6 Months – 18 Months
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adequate completion of informed consent process with written documentation. The participant's legally acceptable representative must have provided the appropriate written informed consent. Assent forms will not be used due to the age of the participant population; however, for procedures later in the study when participants are older, age appropriate assent will be obtained, if required by local Institutional Review Board (IRB).
* Age: 6-18 months of age inclusive at randomization which means 5 to 17 months of age inclusive on entry into the one month run-in period. At least half of all enrolled children will be between 6 and 12 months of age at randomization.
* Participants will meet at least one of the following criteria, which have been associated with an increased risk of wheezing respiratory illnesses and asthma: a) Parental history of asthma -or- b) Physician-diagnosed atopic dermatitis in the participant - or- c) Physician-diagnosed asthma in a blood sibling aged 4 years or more.
* Participants may be either male or female.
* Participants will have at least one parent/guardian who can communicate with the study staff to allow assessment of study outcomes. All study materials used by parent/guardian will be made available in English and in Spanish. The child's parent/guardian must have a working direct contact telephone.
Exclusion Criteria:
* Participants may not have had more than two prior WLRI episodes.
* Participants may not have had any SWL…
What they're measuring
1
The time to the occurrence of the first WLRI episode in the observation period while not receiving study drug
Timeframe: ages 30 to 42 months at the end of treatment; ages 66 to 78 months at completion