Oral Bacterial Extract for the Prevention of Wheezing Lower Respiratory Tract Illness

NCT02148796 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: ORBEX-BV2014/06
• Study Type: interventional
• Target: 822
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Asthma; Wheezing

Keywords

Wheezing; Lower respiratory tract illness; Asthma; Atopy

Outcome Measures

Primary Outcomes (1)

• 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

  ages 30 to 42 months at the end of treatment; ages 66 to 78 months at completion

Secondary Outcomes (8)

• The time to first WLRI during the two treatment years while receiving study drug

  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

  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

  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.

  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.

  ages 30 to 42 months at the end of treatment; ages 66 to 78 months at completion

Other Outcomes (11)

• The proportion of episode free days (EFD) annualized for each year of study.

  Treatment (2 yr) and observation periods

• Time to first systemic corticosteroid course

  Treatment (2 yr) and observation periods

• Number of systemic corticosteroid courses

  Treatment (2 yr) and observation periods

Study Arms (2)

Broncho-Vaxom (BV)

ACTIVE COMPARATOR

One 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.

Drug: Broncho-Vaxom (BV)

Placebo

PLACEBO COMPARATOR

A placebo capsule will be used that will be indistinguishable from the active study drug.

Other: Placebo

Interventions

Broncho-Vaxom (BV) DRUG

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

Also known as: OM-85 BV VEGETAL, Broncho-Vaxom concentrate (bacterial lysate)

Broncho-Vaxom (BV)

Placebo OTHER

A placebo capsule will be used that will be indistinguishable from the active study drug.

Placebo

Eligibility Criteria

• Age: 6 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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 atrial septal defect (ASD), ventricular septal defect (VSD) or benign heart murmur).
• Participants may not have been born earlier than 36 weeks of gestation.
• 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.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (11)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

University of California San Francisco, Benioff Children's Hospital

Oakland, California, 94609, United States

Location

Children's National Health System

Washington D.C., District of Columbia, 20037, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Boston Children's Hospital, Harvard University

Boston, Massachusetts, 02115, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Cincinnati Children's Hospital & Medical Center

Cincinnati, Ohio, 45229, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792-4108, United States

Location

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MeSH Terms

Conditions

Asthma; Respiratory Sounds

Interventions

Broncho-Vaxom

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fernando D Martinez, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

• Wayne J Morgan, MD

  University of Arizona

  STUDY DIRECTOR

• Dave T Mauger, PhD

  Penn State University, Data Coordinating Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 28, 2014
• Study Start: January 1, 2017
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)