Study Treatment Introduction
What is the Study Product?
Participants will either receive a capsule of Broncho-Vaxom or a placebo.
Broncho-Vaxom ® is an extract of different bacterial species frequently responsible for respiratory infections. These bacterial species stimulate the immune system, similar to how a vaccine works, in order to increase the body’s natural defenses agains a wide spectrum of respiratory pathogens. Broncho-Vaxom is currently used in Europe to prevent and/or reduce the severity of chronic bronchitis and recurrent respiratory infections.
The placebo consists of non-active ingredients.
How to Administer Study Product (Broncho-Vaxom or Placebo)
Open the capsule that is filled with a little bit of powder. The powder can then be mixed with fruit juice or other liquid for your child to drink.
When to Administer Study Product
One capsule is to be taken for 10 consecutive days each month, starting on the same day each month.
Possible Adverse Effects
As part of the study your child will be closely monitored, but potential adverse reactions to Broncho-Vaxom include diarrhea (6 out of 100) or headache (5 out of 100), both of which are about the same rate as children who were taking the placebo, which has no active ingredients.
Eligibility to Participate
The ORBEX Study is limited to participants who meet the following requirements:
- Child is between the ages of 5 - 17 months;
- Must meet at least one of the following criteria; and
- One of the child’s parents has asthma or has been diagnosed with asthma in the past
- Child has been diagnosed with eczema
- Child has at least one parent/legal guardian who has a working cell phone and can communicate with study staff.
Other Places Broncho-Vaxom Has Been Used
Effectiveness of Broncho-Vaxom in prevention of recurrent upper respiratory tract infection in children3
Purpose: Evaluation of effectiveness of immunostimulating treatment with Broncho-Vaxom and his influence on concentration of proinflammatory cytokines in children with recurrent upper respiratory tract infection.
Participants: The study comprised 32 children (the average age 8 years and 4 months) with recurrent upper respiratory tract infection received immunostimulating treatment with Broncho-Vaxom. 20 children (the average age 7 years and 8 months) with recurrent upper respiratory tract infection which did not receive treatment with Broncho-Vaxom consisted the control group. In all children clinical state and concentration of cytokines TNF-alpha and, IL-1beta, IL-6, IL-8 in serum was examined. Period of observation in both groups carried out 24 months. Follow-up was executed after 6 months.
Results: The treatment with Broncho-Vaxom shows the high effectiveness in prevention of recurrent upper respiratory tract infection in children as well as the influences of profitable changes in profile of serum cytokines which can impact on limitation the inflammation process in the upper respiratory tract.
Broncho-Vaxom therapy for children with chronic bronchitis4
Purpose: To evaluate the efficacy of Broncho-Vaxom in children with chronic bronchitis.
Results: They observed, during the Broncho-Vaxom therapy, a significant reduction in the number and severity of the acute episodes as well as the significant reduction of the use of antibiotics. They recommend the use of Broncho-Vaxom in chronic, recurrent respiratory infections.
The role of OM-85 BV (Broncho-Vaxom) in preventing recurrent acute tonsillitis in children5
Purpose: To evaluate the efficacy of an immunostimulant (bacterial lysate) Broncho-Vaxom in the management of children with recurrent acute tonsillitis.
Participants: 5-year retrospective cohort study of 177 children presenting with a diagnosis of recurrent acute tonsillitis. 3 months of treatment. The median age of patients was 4.5 years (range: 1–15 years) with 63.8% being males.
Results: A considerable proportion of children receiving Broncho-Vaxom for recurrent acute tonsillitis show a decrease in the frequency of episodes in the short term, and very few patients eventually require tonsillectomy on long-term follow up.
Broncho-Vaxom in children with rhinosinusitis: a double-blind clinical trial6
Purpose: To test the efficacy of Broncho-Vaxom in children with rhinosinusitis. Rhinosinusitis is the inflammation of the nasal passages and sinus cavities. It is usually caused by allergies or an infection.
Participants: Fifty-one children aged 4-12 years, presenting with an acute epidose of chronic rhinosinusitis, were treated for 6 months with either Broncho-Vaxom (BV; marketed in Yugoslavia under the trade mark of Broncho-Munal) or placebo under double-blind randomized conditions.
Results: In BV treated patients the incidence and duration of infectious episodes and the number and duration of concomitant treatments decreased significantly in comparison with the placebo group, and the clinical response correlated positively with an increase in the serum levels of IgA. The results of treatment of acute episodes of chronic rhinosinusitis in children demonstrated the curative and prophylactic efficacy of BV.
Use of Broncho-Vaxom in private practice: phase IV trial in 587 children7.
Purpose: We conducted a Phase IV, open-label clinical trial to test the efficacy and safety of the immunomodulating agent Broncho-Vaxom in private practice.
Participants: The trial comprised 587 children younger than 12 years of age who had an acute respiratory tract infection at entry and a history of recurrent respiratory tract infections. The patients were given one capsule daily, 10 days per month, for 3 consecutive months. During the acute phase of the disease the patients also received antibiotic therapy.
Results: Comparing the infection present at entry with previous infections, the time to improvement (mean +/- SD) decreased from 6.77 +/- 4.42 days to 3.76 +/- 2.18 days, while the time to cure decreased from 11.86 +/- 8.41 days to 7.36 +/- 4.93 days. During the 3 months of therapy, the number of infections decreased from 1.79 +/- 0.96 1 month before treatment to 0.24 +/- 0.46 in the third month of treatment; absenteeism decreased from 3.17 +/- 3.07 days to 0.16 +/- 0.63 days; and the number of antibiotic treatments decreased from 1.71 +/- 1.06 to 0.16 +/- 0.51. In the patients who experienced a recurrent respiratory tract infection during the study, the time to improvement decreased from 5.46 +/- 3.28 days before treatment to 2.79 +/- 1.36 days after treatment, and the time to cure decreased from 8.71 +/- 3.96 days to 4.54 +/- 2.26 days. Adverse events included asthenia and adynamia in 3 patients, diarrhea in 3, rash in 2, fever in 2, exacerbation of symptoms in 2, adenitis in 1, and flulike syndrome in 1. We conclude that Broncho-Vaxom is effective and safe for the treatment of acute episodes of respiratory tract infections and for preventing recurrences.
3 Zielnik-Jurkiewicz B, Jurkiewicz D, Stankiewicz W. [Effectiveness of Broncho-Vaxom® in prevention of recurrent upper respiratory tract infection in children]. Pol Merkur Lekarski. 2005 Nov;19(113):625-9. Polish. PubMed PMID: 16498798.
4 Márialigeti, T., Székely, E., & Kereki, E. (1989). Broncho-Vaxom® therapy for children with chronic bronchitis. Retrieved September 06, 2016, from http://www.ncbi.nlm.nih.gov/pubmed/9001824
5 Bitar, M. A., & Saade, R. (2013). The role of OM-85 BV (Broncho-Vaxom®) in preventing recurrent acute tonsillitis in children. International Journal of Pediatric Otorhinolaryngology, 77(5), 670-673. doi:10.1016/j.ijporl.2013.01.009
6 Zagar, S., & Löfler-Badzek, D. (1988). Broncho-Vaxom® in Children with Rhinosinusitis: A Double-Blind Clinical Trial. Orl, 50(6), 397-404. doi:10.1159/000276020
7 Berber, A. C., & Del-Rio-Navarro, B. E. (1996). Use of Broncho-Vaxom® in private practice: Phase IV trial in 587 children. Clinical Therapeutics, 18(6), 1068-1079. doi:10.1016/s0149-2918(96)80062-2