Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
1076

Inclusion Criterias

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).
Participants may be either male or female.
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.
...
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).
Participants may be either male or female.
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 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.

Exclusion Criterias

Participants may not have been born earlier than 36 weeks of gestation.
Families will speak English and/or Spanish.
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 been born earlier than 36 weeks of gestation.
Families will speak English and/or Spanish.
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 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 atrial septal defect (ASD), ventricular septal defect (VSD) or benign heart murmur).
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 any other chronic lung disease; e.g. chronic lung disease of prematurity (CLDP) or cystic fibrosis.
Participants may not have received inhaled or systemic corticosteroids for respiratory related illness ever, or for other conditions in the month prior to randomization.
Participant has known sensitivity to any of the study products and any of the ingredients to be administered.
Ongoing infection (of any organ system) at the time of randomization. This includes infections that are being adequately treated.
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.
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).
Participants may not have ever received immunotherapy.
Participants may not have had more than two prior WLRI episodes.
Participants may not have a physician's diagnosis of asthma.
Participants may not have significant neurodevelopmental delay.
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.
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.
Unable or unlikely to complete study assessments or the study intervention poses undue risk to patient in the opinion of the Investigator.
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.
Participants may not have had any SWLRI episodes.
Participants may not be below the 3rd percentile for weight.
Participants may not have a history of any life-threatening respiratory illness that required intubation and mechanical ventilation.
Participants may not have ever received i.v. gammaglobulins or systemic immunosuppressants.

Summary

Conditions
  • Asthma
  • Wheezing
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Investigator)
  • Primary Purpose: Prevention

Participation Requirements

Age
Younger than 618 years
Gender
Both males and females

Description

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 ...

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.

Inclusion Criterias

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).
Participants may be either male or female.
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.
...
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).
Participants may be either male or female.
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 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.

Exclusion Criterias

Participants may not have been born earlier than 36 weeks of gestation.
Families will speak English and/or Spanish.
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 been born earlier than 36 weeks of gestation.
Families will speak English and/or Spanish.
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 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 atrial septal defect (ASD), ventricular septal defect (VSD) or benign heart murmur).
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 any other chronic lung disease; e.g. chronic lung disease of prematurity (CLDP) or cystic fibrosis.
Participants may not have received inhaled or systemic corticosteroids for respiratory related illness ever, or for other conditions in the month prior to randomization.
Participant has known sensitivity to any of the study products and any of the ingredients to be administered.
Ongoing infection (of any organ system) at the time of randomization. This includes infections that are being adequately treated.
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.
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).
Participants may not have ever received immunotherapy.
Participants may not have had more than two prior WLRI episodes.
Participants may not have a physician's diagnosis of asthma.
Participants may not have significant neurodevelopmental delay.
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.
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.
Unable or unlikely to complete study assessments or the study intervention poses undue risk to patient in the opinion of the Investigator.
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.
Participants may not have had any SWLRI episodes.
Participants may not be below the 3rd percentile for weight.
Participants may not have a history of any life-threatening respiratory illness that required intubation and mechanical ventilation.
Participants may not have ever received i.v. gammaglobulins or systemic immunosuppressants.

Locations

Cincinnati, Ohio, 45229
Madison, Wisconsin, 53792-4108
Oakland, California, 94609
Atlanta, Georgia, 30322
Washington, District of Columbia, 20037
...
Cincinnati, Ohio, 45229
Madison, Wisconsin, 53792-4108
Oakland, California, 94609
Atlanta, Georgia, 30322
Washington, District of Columbia, 20037
Saint Louis, Missouri, 63110
Boston, Massachusetts, 02115
New York, New York, 10032
Chapel Hill, North Carolina, 27514
Tucson, Arizona, 85724
Phoenix, Arizona, 85016

Tracking Information

NCT #
NCT02148796
Collaborators
Not Provided
Investigators
  • Principal Investigator: Fernando D Martinez, MD University of Arizona Study Director: Wayne J Morgan, MD University of Arizona Study Director: Dave T Mauger, PhD Penn State University, Data Coordinating Center
  • Fernando D Martinez, MD University of Arizona Study Director: Wayne J Morgan, MD University of Arizona Study Director: Dave T Mauger, PhD Penn State University, Data Coordinating Center