Category Archives: Respiratory Tract Infections

Safety and Efficacy of Two Courses of OM-85 BV in the Prevention of Respiratory Tract Infections in Children During 12 Months: Discussion

RTIs are important causes of morbidity, mortality, and disability in children, and therefore are one of the main costs for the health-care system.” In order to reduce the incidence and complications of RTIs, it is necessary to explore new alternatives for the prevention of this kind of infection.
We have presented a trial to investigate the safety and efficacy of the bacterial extracts OM-85 BV covering a period of 12 months with two courses of administration. We tried to exclude the patients with the clinical suspicion of allergy from the trial (familial history of allergy, seasonal or food-related wheezing or nasal itchiness, or nasal folds); yet, presence of allergy cannot be completely ruled out. As the definitions for upper and lower ARTIs overlap with allergy symptoms, it is possible that some allergy clinical pictures were diagnosed as ARTIs. However, the randomization would distribute the effect in both groups.
The mean number of infections showed a reduction in the OM-85 BV group with respect to the placebo group. In contrast, Mexican 6-month trials have showed a reduction in infections of 2.25 ± 0.58 vs 4.68 ± 0.94, ie, 52% (ages, 1 to 11 years), and another reduction of 1.43 ± 0.94 vs 2.99 ± 0.81 (52%) in patients aged 6 to 13 years.
When ARTI data were grouped by calendar months, the OM-85 BV effect was significant from May to August and had a trend from September to December: larger sample sizes would be required to detect these monthly differences. In a previous trial, when all the patients began treatment with the trial medications in September, the preventive effect of OM-85 BV could be demonstrated from October to February.
It is important to note that the number of ARTIs as well as the number of antibiotic courses decreased in both groups regarding the period before the trial. It is possible that as the children grew older, they had a lower incidence of ARTI or that there had been a previous overreport. The reduction in the use of antibiotic may be ascribed to the decrease in the number of ARTIs and to close follow-up of the patients. It was not possible to detect a consistent effect of the medication in the severity of ARTIs, because of the small number of patients suffering from ARTIs in the OM-85 BV group.

Safety and Efficacy of Two Courses of OM-85 BV in the Prevention of Respiratory Tract Infections in Children During 12 Months: Results2

Safety and Efficacy of Two Courses of OM-85 BV in the Prevention of Respiratory Tract Infections in Children During 12 Months: Results2The numbers of patients included per month from July 1997 to February 1998 were 5, 1, 8, 12, 11, 5, 7, and 5, respectively. Table 4 contains the mean and SDs and difference for the trial end points; the number of ARTIs; illness duration; number of antibiotic courses; number of drug courses (treatment courses including antibiotics); duration of concomitant treatment (number of days receiving any drug treatment); and days out of school. Lung Cancer
Except for the absenteeism, the cumulative figures of the end points showed a significant difference between the groups from the second month of the trial to the end of the trial (p < 0.05 by Student’s t test, and Mann-Whitney U test). The ANOVA for repeated measures for the monthly evolution of such variables (except absenteeism) showed a significant difference between the groups and within the groups as well as significant interaction of the effect of the groups and the different measures throughout the trial (p < 0.01).
Regarding the monthly severity score in visual analog scale for consecutive months, there were significant differences (p < 0.05 by Student’s t test) in month 2 (OM-85 BV 21.81 ± 6.81 vs placebo 30.64 ± 13.02) and month 12 (20.61 ± 5.61 vs 30.47 ± 12.05, respectively).
If we only considered the children with ages < 6 years, the OM-85 BV group (n = 23) had 4.87 ± 1.94 ARTIs and the placebo group (n = 21) had 8.28 ± 2.85 (p < 0.01 by Student’s t test and Mann-Whitney U test), ie, a difference of — 3.42 (95% CI, — 4.92 to — 1.91), 41.18% fewer infections.

Safety and Efficacy of Two Courses of OM-85 BV in the Prevention of Respiratory Tract Infections in Children During 12 Months: Results

Fifty-four of 100 children were selected to enter the trial. The nonincluded children suffered seasonal or food-related wheezing or nasal itchiness. Patients were reminded of follow-up visits. Only one boy in the OM-85 BV group was unavailable for follow-up in the last assessment, and the rest of the trial participants completed the scheduled clinical assessments.
All the envelopes containing the double-blind code for the treatment numbers were collected after the end of the study. Based on the empty blisters, compliance was > 90% in all the patients. In the OM-85 BV group, 18 children received powder and 8 children received capsules; in the placebo group, 16 children received powder and 12 children received capsules.
Both groups had similar demographics at the beginning of the trial (p > 0.05; Table 1). The reported ARTIs incidence the year before was > 12 in both groups. Most of these ARTIs were from mild-to-moderate severity. The risks factors for ARTIs were similar (p > 0.05), except the number of siblings in the school that was higher in the placebo group (Table 2). Twenty children in the OM-85 BV group and 17 in the control group had antecedents of otitis with moderate severity; they suffered 2.45 ± 1.1 and 2.53 ± 2.03 otitis episodes in the last year, respectively. Treatment thrombosis
During the trial, 131 ARTIs were recorded in the OM-85 BV group and 224 in the placebo group (Table 3). The patients in the OM-85 BV group had a lower relative risk of one or more otitis episodes of 0.323 (95% confidence intervals [CI], 0.100 to 1.046; a trend for a lower risk), as well as lower relative risks for six or more, seven or more, or eight or more ARTIs of 0.374 (95% CI, 0.205 to 0.684), 0.323 (95% CI, 0.154 to 0.677), and 0.287 (95% CI, 0.109 to 0.754), respectively.
Figure 1 represents the mean incidence of ARTIs from data organized in calendar months. There were significant lower incidences of ARTIs in the months of May, June, July, and August in the OM-85 BV group (p < 0.05 by Mann-Whitney U test), and a trend from January to March and from September to December. Figure 2 represents the percentage of patients having less than six ARTIs throughout the consecutive 12-month period. The OM-85 BV group had fewer ARTIs than the placebo group.

Safety and Efficacy of Two Courses of OM-85 BV in the Prevention of Respiratory Tract Infections in Children During 12 Months: ARTIs

Safety and Efficacy of Two Courses of OM-85 BV in the Prevention of Respiratory Tract Infections in Children During 12 Months: ARTIsPatients were assessed monthly and every time they presented respiratory symptoms, and all the ARTIs were followed up to the complete disappearance of all the symptoms. All the physical examinations and drug prescriptions were made by one of the authors (M.D.G.T.). Antibiotics were prescribed when purulent secretions were present, or in the case of otitis or lower ARTI. The medication codes were enclosed in opaque sealed envelopes and kept available for the researcher in the study center to be opened in case of a serious adverse event. The trial began in July 1997 and was completed by April 1999. Patients were recruited from July 1997 to April 1998.
The characteristics of ARTIs were registered on the case report form as they occurred: type (upper, lower, or otitis) and number of infections (main end point), and when a child had school absenteeism secondary to an ARTI (as days out of school due to ARTIs), number of antibiotic or other drug courses (any drug course including antibiotics), duration of the treatment (days taking any medication), and time of convalescence (days elapsed to clinical cure assessed) (secondary end points). my canadian pharmacy

The end point differences between the groups were analyzed by analysis of variance (ANOVA) for repeated measures, Student’s t test, and Mann-Whitney U test using statistical software (SPSS; Chicago, IL). Additionally, the relative risks for more than six, more than seven, and more than eight ARTIs and more than one otitis were calculated, as well as the comparison of rate of patients having less than six ARTIs throughout the 12-month period by Kaplan-Meier statistics.
Two infections were counted as such only when the patient was without symptoms for at least 72 h between the end and the beginning of the episodes. A treatment course was considered as such, when at least one drug dosage for 1 day of treatment was completed.

Safety and Efficacy of Two Courses of OM-85 BV in the Prevention of Respiratory Tract Infections in Children During 12 Months: Materials and Methods

A placebo-controlled, parallel, prospective trial was conducted. The patients were children from 1 to 12 years of age Living in the metropolitan area of Chihuahua City, Chihuahua State, Mexico. The families were cared for under the state (Pensiones Civiles de Chihuahua, free medical services for workers of state government).
An upper ARTI was defined as the presence of at least one of the following signs: rhinorrhea; sore throat or cough, without signs of lower ARTI, for > 48 h. Lower ARTI was defined as the presence of at least one of the following signs: rales or crepitations, wheezing, stridor, respiratory rate > 50/min, cyanosis, or chest indrawing for > 48 h. Otitis was defined as acute onset of earache with erythema and limited mobility of the tympanic membrane determined by pneumatic otoscopy. Similar upper and lower ARTI definitions have been used in epidemiologic studies in developing countries. canadian neightbor pharmacy

In a previous clinical trial in Mexico, the placebo group presented 2.99 ± 0.81 ARTIs in 6 months; therefore, we projected about 6 ± 1.6 ARTIs in a 12-month period, and a 50% reduction in the incidence of ARTI according to previous trials in Mexico. Considering a difference of 3.0 ± 3.0 ARTIs between the groups during 12 months, the calculated sample size by group was 23, as calculated by software (Primer on Statistics 3.0; Mc-Graw-Hffl; New York, NY).
The selection criteria were as follows: at least three ARTIs registered on clinical files of the social security system during the previous 6 months; negative familial history of allergy; no seasonal or food-related wheezing and nasal itchiness; absence of nasal folds, with no anatomic alterations of the respiratory tract by physical examination; chronic respiratory diseases (tuberculosis, cystic fibrosis); autoimmune diseases; liver failure; kidney failure, malnutrition, or cancer; and no treatment with corticosteroids, immunosuppressants, immunostimulants, 7-globulins, or anticonvulsive drugs in the last 6 months.
Informed consent for each participant was obtained from the parents at entry. Children > 3 years old gave their oral consent. The protocol and case report form were approved by the local committee of investigation and ethics and were performed according to the Mexican regulation and the Helsinki Declaration of 1975, as revised in 1983.

Safety and Efficacy of Two Courses of OM-85 BV in the Prevention of Respiratory Tract Infections in Children During 12 Months

Safety and Efficacy of Two Courses of OM-85 BV in the Prevention of Respiratory Tract Infections in Children During 12 MonthsRespiratory tract infections (RTIs) are considered by the World Health Organization as the forgotten pandemic; they are the worldwide main cause of death in children < 5 years old and produce 8.2% of the total disease burden. In the developed countries, RTIs are the leading cause of morbidity, accounting for 20% of medical consultations, 30% of labor absenteeism. and 75% of all antibiotic prescriptions. Acute RTIs (ARTIs) in children are associated with acute otitis media, which is an important cost for health-care services and can be related to hearing loss2 and learning problems,- even in those treated properly.
The main measure to avoid deaths and disabilities related to RTI is to prevent these infections and provide early antibiotic treatment when indicat-ed.’’ Several interventions to induce nonspecific protection against ARTIs have been recently studied, such as zinc supplementation, administration of Echinacea purpurea extract, as well as intranasally administered immunoglobulins for the prevention of rhinitis, and the use of xylitol sugar syrup and chewing gum for protection against otitis media. canadian health and care mall

On this line, OM-85 BV (bronchovaxom; OM PHARMA; Geneva, Switzerland; marketed in Mexico by Quimica Knoll de Mexico) is an immunos-timulant for the prevention of ARTIs. OM-85 BV is the product of alkaline proteolysis from lysates of the following bacteria: Haemophilus influenzae; Streptococcus pneumoniae; Klebsiella pneumoniae; Klebsiella ozaenae; Staphylococcus aureus; Staphylococcus pyogenes; Streptococcus viridans; Moraxella catarrha-lis.13 Each strain contributes the same relative proportion to the total protein. OM-85 BV is mainly made of d-amino acids polypeptides (data on file).
OM-85 BV is free of lipopolysaccharides; therefore, it does not act on lipopolysaccharides receptor CD 14. In macrophage and monocytic cells, OM-85 BV increases intracellular calcium levels and induces the production of glucose regulated protein 7815 and c-fos/serum response element protein. These second messengers induce the expression of proinflammatory cytokines interleukin (IL)-1a, IL-6, IL-8, and tumor necrosis factor-a. Additionally, OM-85 BV induces phagocytic cells to produce nitric oxide and oxygen, and to express adhesion molecules.
Patients receiving OM-85 BV have shown enhancement of cellular immune responses, increase in secretory IgA and serum IgA, serum IgG and IgM,> and activation of phagocytic cells.> OM-85 BV has shown safety and efficacy in the prevention of ARTIs in exposed children attending day-care centers and orphanages and in highly susceptible children.> OM-85 BV has been shown to have some effect on children suffering from immune system defects such as IgG or IgA deficiency and common variable immunodeficiency.