Asthma | Oral Bacterial Extract for the Prevention of Wheezing Lower Respiratory Tract Illness
Asthma research study
What is the primary objective of this study?
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 third observation year after therapy
Who is eligible to participate?
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 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. - 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 SWLRI episodes. - Participants may not have a physician's diagnosis of asthma. - Participants may not have a systemic illness (other than allergy) including (but not limited to) recurrent seizures, chronic gastroesophageal reflux (GER) requiring medical treatment, major congenital anomalies, physical and intellectual delay, cerebral palsy, chest surgery, tuberculosis or other chronic infections, primary or secondary immunodeficiency, gastrointestinal malformation or disease or cardiac disorder (except a hemodynamically insignificant ASD, VSD or benign heart murmur). - Participants may not have been born earlier than 36 weeks of gestation. - Participants may not have received oxygen for more than 5 days in the neonatal period, or received mechanical ventilation with the exclusion of ventilation during anesthesia for a minor surgical procedure. - Participants may not have significant neurodevelopmental delay. - Participants may not be below the 3rd percentile for weight. - Participants may not have any other chronic lung disease; e.g. chronic lung disease of prematurity (CLDP) or cystic fibrosis. - Participants may not have a history of any life-threatening respiratory illness that required intubation and mechanical ventilation. - The participant's family may not be expected to relocate out of study area within 3 years of the initiation of the study. - Participants may not have received inhaled or systemic corticosteroids for respiratory related illness ever, or for other conditions in the month prior to randomization. - Participants may not have ever received immunotherapy. - Participants may not have ever received i.v. gammaglobulins or systemic immunosuppressants. - Participants may not have received probiotics (Lactobacilli and Bifidobacteria) in medicinal form; (i.e. not including food), regularly for more than 4 months in the 6 to <12 mo age group or 6 months in the 12 to 18 month group prior to enrollment. - Participant has known sensitivity to any of the study products and any of the ingredients to be administered. - Participant has previously been randomized in this study. Participants who failed run-in and were not randomized may have study participation terminated and then be re-enrolled for a second run-in period. - Participant is currently enrolled in or has completed any other investigational device or drug study <30 days prior to screening, or is receiving other investigational agent(s). - Participant has a significant medical condition(s), anticipated need for major surgery during the study, or any other kind of disorder that may be associated with increased risk to the participant, or may interfere with study assessments, outcomes, or the ability to provide written informed consent or comply with study procedures, in the Investigator's opinion. - The one month run-in period will be used to evaluate adherence to study drug administration and electronic communication. At randomization the participant must continue to meet enrolment criteria and also have demonstrated 80% adherence to the placebo during treatment period; i.e. 8 out of 10 days and a75% response rate to weekly mobile phone text queries; i.e. 3 out of 4 weekly text queries. - Ongoing infection (of any organ system) at the time of randomization. This includes infections that are being adequately treated. - Unable or unlikely to complete study assessments or the study intervention poses undue risk to patient in the opinion of the Investigator. - Families will speak English and/or Spanish.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Broncho-VaxomActive 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 SA, Switzerland; Storage: Store in the original package
Other:PlaceboA placebo capsule will be used that will be indistinguishable from the active study drug.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Broncho-VaxomOne 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.
PlaceboA placebo capsule will be used that will be indistinguishable from the active study drug.
Start Date: January 3, 2017
Completed Date: April 30, 2022
Phase: Phase 2
Primary Outcome: The time to the occurrence of the first WLRI episode in the third observation year while not receiving study drug
Secondary Outcome: The time to first WLRI during the two treatment years while receiving study drug
Study sponsors, principal investigator, and references
Principal Investigator: Fernando D Martinez, MD
Lead Sponsor: University of Arizona
Ahanchian H, Jones CM, Chen YS, Sly PD. Respiratory viral infections in children with asthma: do they matter and can we prevent them? BMC Pediatr. 2012 Sep 13;12:147. doi: 10.1186/1471-2431-12-147.