AsthmaPhase 2ORBEXNCT02148796
Oral Bacterial Extract for the Prevention of Wheezing Lower Respiratory Tract Illness
A Phase 2 study testing Broncho-Vaxom (BV) in people with Asthma and Wheezing, run by University of Arizona at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 monthsHealthy volunteers can take part
- What is being tested?
- Broncho-Vaxom (BV)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 822 participants
- Where
- 11 sitesUnited States
- Study dates
- 1 Jan 2017to 30 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 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.
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- 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 enrollment 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Emory University
Atlanta, Georgia, 30322
Boston Children's Hospital, Harvard University
Boston, Massachusetts, 02115
University of North Carolina
Chapel Hill, North Carolina, 27514
Cincinnati Children's Hospital & Medical Center
Cincinnati, Ohio, 45229
University of Wisconsin
Madison, Wisconsin, 53792-4108
Columbia University
New York, New York, 10032
University of California San Francisco, Benioff Children's Hospital
Oakland, California, 94609
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Washington University
St Louis, Missouri, 63110
University of Arizona
Tucson, Arizona, 85724
Children's National Health System
Washington D.C., District of Columbia, 20037
About this study
Official title: Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of ORal Bacterial EXtract for the Prevention of Wheezing Lower Respiratory Tract Illness (ORBEX)
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.
Read the detailed 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 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.
- Being tested
- Broncho-Vaxom (BV), Placebo
- Keywords
- Wheezing, Lower respiratory tract illness, Asthma, Atopy
- Medical subject headings
- Asthma, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broncho-Vaxom (BV)Drug
Also called OM-85 BV VEGETAL, Broncho-Vaxom concentrate (bacterial lysate)
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
PlaceboOther
A placebo capsule will be used that will be indistinguishable from the active study drug.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Broncho-Vaxom (BV) |
| Placebo | Placebo comparator | A placebo capsule will be used that will be indistinguishable from the active study drug. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
The time to first WLRI during the two treatment years while receiving study drug
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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").
Measured: 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
Measured: 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.
Measured: ages 30 to 42 months at the end of treatment; ages 66 to 78 months at completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study start1 Jan 2017
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (59)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 822 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernando D Martinez, MD, Principal investigator, University of ArizonaWayne J Morgan, MD, Study director, University of ArizonaDave T Mauger, PhD, Study director, Penn State University, Data Coordinating Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148796
- Sponsor's protocol ID
- ORBEX-BV2014/06
- Acronym
- ORBEX
- Status last verified
- Feb 2026
- First submitted
- 19 May 2014
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Within 6 months of publication, individual participant data will be deposited into the NHLBI BioLINCC data repository (biolincc.nhlbi.nih.gov). The data will be de-identified and accompanied by the data dictionary, study protocol, and case report forms.
Publications
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.
PubMed 22974166Azad MB, Coneys JG, Kozyrskyj AL, Field CJ, Ramsey CD, Becker AB, Friesen C, Abou-Setta AM, Zarychanski R. Probiotic supplementation during pregnancy or infancy for the prevention of asthma and wheeze: systematic review and meta-analysis. BMJ. 2013 Dec 4;347:f6471. doi: 10.1136/bmj.f6471.
PubMed 24304677Becker A, Watson W, Ferguson A, Dimich-Ward H, Chan-Yeung M. The Canadian asthma primary prevention study: outcomes at 2 years of age. J Allergy Clin Immunol. 2004 Apr;113(4):650-6. doi: 10.1016/j.jaci.2004.01.754.
PubMed 15100668Beydon N, Davis SD, Lombardi E, Allen JL, Arets HG, Aurora P, Bisgaard H, Davis GM, Ducharme FM, Eigen H, Gappa M, Gaultier C, Gustafsson PM, Hall GL, Hantos Z, Healy MJ, Jones MH, Klug B, Lodrup Carlsen KC, McKenzie SA, Marchal F, Mayer OH, Merkus PJ, Morris MG, Oostveen E, Pillow JJ, Seddon PC, Silverman M, Sly PD, Stocks J, Tepper RS, Vilozni D, Wilson NM; American Thoracic Society/European Respiratory Society Working Group on Infant and Young Children Pulmonary Function Testing. An official American Thoracic Society/European Respiratory Society statement: pulmonary function testing in preschool children. Am J Respir Crit Care Med. 2007 Jun 15;175(12):1304-45. doi: 10.1164/rccm.200605-642ST. No abstract available.
PubMed 17545458Bisgaard H, Hermansen MN, Buchvald F, Loland L, Halkjaer LB, Bonnelykke K, Brasholt M, Heltberg A, Vissing NH, Thorsen SV, Stage M, Pipper CB. Childhood asthma after bacterial colonization of the airway in neonates. N Engl J Med. 2007 Oct 11;357(15):1487-95. doi: 10.1056/NEJMoa052632.
PubMed 17928596Bluestone JA, Auchincloss H, Nepom GT, Rotrosen D, St Clair EW, Turka LA. The Immune Tolerance Network at 10 years: tolerance research at the bedside. Nat Rev Immunol. 2010 Nov;10(11):797-803. doi: 10.1038/nri2869.
PubMed 20972473Bousquet J, Anto J, Auffray C, Akdis M, Cambon-Thomsen A, Keil T, Haahtela T, Lambrecht BN, Postma DS, Sunyer J, Valenta R, Akdis CA, Annesi-Maesano I, Arno A, Bachert C, Ballester F, Basagana X, Baumgartner U, Bindslev-Jensen C, Brunekreef B, Carlsen KH, Chatzi L, Crameri R, Eveno E, Forastiere F, Garcia-Aymerich J, Guerra S, Hammad H, Heinrich J, Hirsch D, Jacquemin B, Kauffmann F, Kerkhof M, Kogevinas M, Koppelman GH, Kowalski ML, Lau S, Lodrup-Carlsen KC, Lopez-Botet M, Lotvall J, Lupinek C, Maier D, Makela MJ, Martinez FD, Mestres J, Momas I, Nawijn MC, Neubauer A, Oddie S, Palkonen S, Pin I, Pison C, Rance F, Reitamo S, Rial-Sebbag E, Salapatas M, Siroux V, Smagghe D, Torrent M, Toskala E, van Cauwenberge P, van Oosterhout AJ, Varraso R, von Hertzen L, Wickman M, Wijmenga C, Worm M, Wright J, Zuberbier T. MeDALL (Mechanisms of the Development of ALLergy): an integrated approach from phenotypes to systems medicine. Allergy. 2011 May;66(5):596-604. doi: 10.1111/j.1398-9995.2010.02534.x. Epub 2011 Jan 24.
PubMed 21261657Carroll KN, Gebretsadik T, Griffin MR, Wu P, Dupont WD, Mitchel EF, Enriquez R, Hartert TV. Increasing burden and risk factors for bronchiolitis-related medical visits in infants enrolled in a state health care insurance plan. Pediatrics. 2008 Jul;122(1):58-64. doi: 10.1542/peds.2007-2087.
PubMed 18595987Castro-Rodriguez JA, Holberg CJ, Wright AL, Martinez FD. A clinical index to define risk of asthma in young children with recurrent wheezing. Am J Respir Crit Care Med. 2000 Oct;162(4 Pt 1):1403-6. doi: 10.1164/ajrccm.162.4.9912111.
PubMed 11029352Collet JP, Ducruet T, Kramer MS, Haggerty J, Floret D, Chomel JJ, Durr F. Stimulation of nonspecific immunity to reduce the risk of recurrent infections in children attending day-care centers. The Epicreche Research Group. Pediatr Infect Dis J. 1993 Aug;12(8):648-52. doi: 10.1097/00006454-199308000-00005.
PubMed 8414777Del-Rio-Navarro BE, Espinosa Rosales F, Flenady V, Sienra-Monge JJ. Immunostimulants for preventing respiratory tract infection in children. Cochrane Database Syst Rev. 2006 Oct 18;2006(4):CD004974. doi: 10.1002/14651858.CD004974.pub2.
PubMed 17054227De Prost Y - Clinical Study Report (BV-2002/1) Multicentric, randomized, double-blind, placebo-controlled study of the efficacy and safety of Broncho-Vaxom® (OM-85 BV) in children suffering from atopic dermatitis. - Clinical Study Report (30 January 2008).
Ege MJ, Mayer M, Normand AC, Genuneit J, Cookson WO, Braun-Fahrlander C, Heederik D, Piarroux R, von Mutius E; GABRIELA Transregio 22 Study Group. Exposure to environmental microorganisms and childhood asthma. N Engl J Med. 2011 Feb 24;364(8):701-9. doi: 10.1056/NEJMoa1007302.
PubMed 21345099Evans SE, Scott BL, Clement CG, Larson DT, Kontoyiannis D, Lewis RE, Lasala PR, Pawlik J, Peterson JW, Chopra AK, Klimpel G, Bowden G, Hook M, Xu Y, Tuvim MJ, Dickey BF. Stimulated innate resistance of lung epithelium protects mice broadly against bacteria and fungi. Am J Respir Cell Mol Biol. 2010 Jan;42(1):40-50. doi: 10.1165/rcmb.2008-0260OC. Epub 2009 Mar 27.
PubMed 19329554FDA Center for Drug Evaluation and Research (CDER) - Orally Inhaled and Intranasal Corticosteroids: Evaluation of the Effects on Growth in Children. Guidance for Industry: March 2007.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of ORal Bacterial EXtract for the Prevention of Wheezing Lower Respiratory Tract Illness (ORBEX)
- ClinicalTrials.gov ID
- NCT02148796
- Acronym / sponsor ID
- ORBEX / ORBEX-BV2014/06
- Keywords
- Wheezing, Lower respiratory tract illness, Asthma, Atopy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 822 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Broncho-Vaxom (BV) | Active comparator | Drug: Broncho-Vaxom (BV)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. |
| Placebo | Placebo comparator | Other: PlaceboA placebo capsule will be used that will be indistinguishable from the active study drug. |
Who may qualify
- Ages
- 6 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Broncho-Vaxom (BV)Also: OM-85 BV VEGETAL, Broncho-Vaxom concentrate (bacterial lysate)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 | Drug | Broncho-Vaxom (BV) |
| PlaceboA placebo capsule will be used that will be indistinguishable from the active study drug. | Other | Placebo |
Primary outcome
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 the occurrence of the first WLRI episode in the observation period while not receiving study drug
8 secondary outcomes
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
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
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.
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.
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
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.
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.
Time frame: ages 30 to 42 months at the end of treatment; ages 66 to 78 months at completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Background: PubMed 22974166Ahanchian 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.
- Background: PubMed 24304677Azad MB, Coneys JG, Kozyrskyj AL, Field CJ, Ramsey CD, Becker AB, Friesen C, Abou-Setta AM, Zarychanski R. Probiotic supplementation during pregnancy or infancy for the prevention of asthma and wheeze: systematic review and meta-analysis. BMJ. 2013 Dec 4;347:f6471. doi: 10.1136/bmj.f6471.
- Background: PubMed 15100668Becker A, Watson W, Ferguson A, Dimich-Ward H, Chan-Yeung M. The Canadian asthma primary prevention study: outcomes at 2 years of age. J Allergy Clin Immunol. 2004 Apr;113(4):650-6. doi: 10.1016/j.jaci.2004.01.754.
- Background: PubMed 17545458Beydon N, Davis SD, Lombardi E, Allen JL, Arets HG, Aurora P, Bisgaard H, Davis GM, Ducharme FM, Eigen H, Gappa M, Gaultier C, Gustafsson PM, Hall GL, Hantos Z, Healy MJ, Jones MH, Klug B, Lodrup Carlsen KC, McKenzie SA, Marchal F, Mayer OH, Merkus PJ, Morris MG, Oostveen E, Pillow JJ, Seddon PC, Silverman M, Sly PD, Stocks J, Tepper RS, Vilozni D, Wilson NM; American Thoracic Society/European Respiratory Society Working Group on Infant and Young Children Pulmonary Function Testing. An official American Thoracic Society/European Respiratory Society statement: pulmonary function testing in preschool children. Am J Respir Crit Care Med. 2007 Jun 15;175(12):1304-45. doi: 10.1164/rccm.200605-642ST. No abstract available.
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- BackgroundDe Prost Y - Clinical Study Report (BV-2002/1) Multicentric, randomized, double-blind, placebo-controlled study of the efficacy and safety of Broncho-Vaxom® (OM-85 BV) in children suffering from atopic dermatitis. - Clinical Study Report (30 January 2008).
- Individual participant dataSharing planned: Yes. Within 6 months of publication, individual participant data will be deposited into the NHLBI BioLINCC data repository (biolincc.nhlbi.nih.gov). The data will be de-identified and accompanied by the data dictionary, study protocol, and case report forms.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando D Martinez, MD principal investigator
University of Arizona
Wayne J Morgan, MD study director
University of Arizona
Dave T Mauger, PhD study director
Penn State University, Data Coordinating Center
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Broncho-Vaxom (BV) in people with Asthma and Wheezing, run by University of Arizona at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02148796, which also lists 59 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.