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The purpose of this study is to determine whether OM-85 BV (Broncho-Vaxom)has any effect on respiratory infections, infection related wheezing attacks, beta-2 agonist use, duration of attacks and effect on serum cytokine levels.
Context: Respiratory infections are the major cause of wheezing attacks in children with recurrent wheezing or asthma in preschool age. OM-85 BV is an bacteria lysate which has been proven to prevent respiratory infections about 40 percent in children.
Objective: To determine if using OM-85 BV diminish the number and duration of the respiratory infections and respiratory infection related wheezing attacks,beta-2 agonist and steroid use, and number and duration of hospitalizations in children with recurrent wheezing and asthma. And also to determine if OM-85 BV has any effect on serum cytokine levels after 6 months.
Study Design/Setting/Participants: A double-blind, randomized, controlled trial of OM-85 BV versus placebo for children 6 months to 6 years of age who have respiratory tract infection related recurrent wheezing attacks.
Intervention: Participants will receive either active Broncho-Vaxom or placebo for 3 months.
Study Measures: They follow up for 1 year for number and duration of wheezing attacks, number, type and duration of respiratory infections, number and duration of beta-2 agonist use, number and duration of steroid use and number and duration of hospitalizations. Serum cytokine levels will measure to determine if Broncho-Vaxom has any effect on serum cytokine levels (at the beginning of the trial and sixth months of the trial).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Broncho-Vaxom | Active Comparator | The children received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months. |
|
| 2 (Placebo OM-85 BV) | Placebo Comparator | The children received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OM-85 BV (Broncho-Vaxom) | Drug | 3.5 mg capsule, 1 capsule per day for first 10 day of the month, for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Rate of Wheezing Attacks | Acute wheezing attack was defined as episode of progressive increase in shortness of breath, cough, wheezing, retraction of the chest and chest tightness, or combination of these symptoms. When wheezing attack occured it was Over the 12 months of the study mean number (rate) of wheezing attacks/per patient was calculated and compared with placebo. This outcome measure was calculated by dividing cumulative wheezing attacks to number of participants in each group. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Duration (in Day) of Wheezing Attacks Per Patient | Over the 12 months of the study we calculated mean duration of each wheezing attacks/per patients.This measure was calculated separately for each participants by dividing duration of wheezing attacks to number of wheezing attacks. | 12 months |
| Number of Common Cold |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| C H RAZI, MD | Kecioren Education and Training Hospital | Study Director |
| C H Razi, MD | Kecioren Education and Training Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kecioren Education and Training Hospital | Ankara | Kec.oren | 06380 | Turkey (Türkiye) | ||
| Keçiören Education and Training Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20920766 | Background | Razi CH, Harmanci K, Abaci A, Ozdemir O, Hizli S, Renda R, Keskin F. The immunostimulant OM-85 BV prevents wheezing attacks in preschool children. J Allergy Clin Immunol. 2010 Oct;126(4):763-9. doi: 10.1016/j.jaci.2010.07.038. |
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This study comprise 3 months of active treatment and 9 months of follow-up. Duration of the trial was 12 months.
Eighty of 100 children were selected to enter the trial. 20 children were not included in to the study because of not meeting the inclusion criteria.
This study was a randomized, double-blind, placebo-controlled, parallel group study with OM-85 (Broncho-Vaxom; OM PHARMA; Meyrin/Geneva, Switzerland) in patients with recurrent wheezing and performed between August 2007- September 2008 in the outpatient department of Pediatric Allergy of Kecioren Education and Research Hospital in Ankara, Turkey.
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| ID | Title | Description |
|---|---|---|
| FG000 | Broncho-Vaxom Group | The children received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months. |
| FG001 | Placebo Group | The children received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Broncho-Vaxom Group | This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months. |
| BG001 | Placebo Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Rate of Wheezing Attacks | Acute wheezing attack was defined as episode of progressive increase in shortness of breath, cough, wheezing, retraction of the chest and chest tightness, or combination of these symptoms. When wheezing attack occured it was Over the 12 months of the study mean number (rate) of wheezing attacks/per patient was calculated and compared with placebo. This outcome measure was calculated by dividing cumulative wheezing attacks to number of participants in each group. | Posted | Mean | Standard Error | wheezing attacks/per patient | 12 months |
|
6 months
3 patients receiving OM-85, and 2 patients receiving placebo reported 5 adverse reactions.These were diarrhea (1 patient), abdominal pain (1 patient) and erythema nodosum (one patient) in the OM-85 group and diarrhea (1 patient), abdominal pain (1 patient) in the placebo group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Broncho-Vaxom Group | This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
Main shortcoming of our study is the small sample size. This might have hampered the appearance of some statistically meaningful differences such as wheezing attacks that require steroid treatment, rate and duration of hospitalizations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cem Hasan RAZİ | Kecioren Education and Training Hospital | 090 312 3659000 | 1139 | cemrazi2@gmail.com |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D012135 | Respiratory Sounds |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C030259 | Broncho-Vaxom |
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| OM-85 BV (placebo) | Drug | 3.5 mg oral placebo capsule, 1 placebo capsule per day for first 10 days of the months for 3 months |
|
|
All the common colds were recorded during the 12 months of the study. At the and of the study period the two groups were compared according to the number of common-cold/per patient over the 12 months of the trial. This outcome was calculated by dividing cumulative number of common colds by number of participants in each group over the 12 months of the trial. |
| 12 months |
| Number of Wheezing Attacks That Required Systemic Steroid Therapy | All the wheezing attacks which were enough severe to require systemic steroid therapy were recorded over the 12 months of the study. At the and of the study period, number of wheezing attacks that required systemic steroid therapy/per patients were calculated. This outcome was calculated by dividing cumulative number of wheezing attacks that required systemic steroid therapy by number of participants in each group. | 12 months |
| Number of Hospitalizations | During the study period of 12 months all hospitalizations for wheezing attacks were recorded. Over the 12 months of the trial mean number of hospitalizations/per patients were calculated. This outcome was calculated by dividing cumulative number of hospitalizations by number of participants in each group over the 12 months of the trial. | 12 months |
| Duration of Hospitalization/Per Patient | Over the 12 months of the study we calculated mean duration of hospitalization/per patients. | 12 months |
| Effect of OM-85 BV on Cytokine Levels | Cytokine levels were not measured during the trial because of unavailability of laboratory resources. | 6 months |
| Ankara |
| Keçiören |
| 06380 |
| Turkey (Türkiye) |
| moved to another place |
|
This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo Group |
This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months. |
|
|
|
| Secondary | Mean Duration (in Day) of Wheezing Attacks Per Patient | Over the 12 months of the study we calculated mean duration of each wheezing attacks/per patients.This measure was calculated separately for each participants by dividing duration of wheezing attacks to number of wheezing attacks. | Posted | Mean | Standard Error | day/per patient | 12 months |
|
|
|
|
| Secondary | Number of Common Cold | All the common colds were recorded during the 12 months of the study. At the and of the study period the two groups were compared according to the number of common-cold/per patient over the 12 months of the trial. This outcome was calculated by dividing cumulative number of common colds by number of participants in each group over the 12 months of the trial. | Posted | Mean | Standard Error | common cold/per patients | 12 months |
|
|
|
|
| Secondary | Number of Wheezing Attacks That Required Systemic Steroid Therapy | All the wheezing attacks which were enough severe to require systemic steroid therapy were recorded over the 12 months of the study. At the and of the study period, number of wheezing attacks that required systemic steroid therapy/per patients were calculated. This outcome was calculated by dividing cumulative number of wheezing attacks that required systemic steroid therapy by number of participants in each group. | Posted | Mean | Standard Error | wheezing attacks/per patient | 12 months |
|
|
|
|
| Secondary | Number of Hospitalizations | During the study period of 12 months all hospitalizations for wheezing attacks were recorded. Over the 12 months of the trial mean number of hospitalizations/per patients were calculated. This outcome was calculated by dividing cumulative number of hospitalizations by number of participants in each group over the 12 months of the trial. | Posted | Mean | Standard Error | hospitalization/per patient | 12 months |
|
|
|
|
| Secondary | Duration of Hospitalization/Per Patient | Over the 12 months of the study we calculated mean duration of hospitalization/per patients. | Posted | Mean | Standard Error | day/per patient | 12 months |
|
|
|
|
| Secondary | Effect of OM-85 BV on Cytokine Levels | Cytokine levels were not measured during the trial because of unavailability of laboratory resources. | Not Posted | 6 months |
| 0 |
| 35 |
| 3 |
| 35 |
| EG001 | Placebo Group | This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months. | 0 | 40 | 2 | 40 |
| abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| erythema nodosum | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |