Effect of OM-85 BV on Wheezing Related Morbidity in Children With Recurrent Wheezing
This study has been completed.
Sponsor:
Kecioren Education and Training Hospital
Information provided by (Responsible Party):
Cem Hasan Razi, Kecioren Education and Training Hospital
ClinicalTrials.gov Identifier:
NCT00733226
First received: August 11, 2008
Last updated: December 17, 2011
Last verified: December 2011
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Results First Received: December 16, 2009
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Prevention |
| Condition: |
Asthma |
| Interventions: |
Drug: OM-85 BV (Broncho-Vaxom) Drug: OM-85 BV (placebo) |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| 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. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
|
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. |
Reporting Groups
| Description | |
|---|---|
| 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. |
| 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. |
Participant Flow: Overall Study
| Broncho-Vaxom Group | Placebo Group | |
|---|---|---|
| STARTED | 40 | 40 |
| COMPLETED | 35 | 40 |
| NOT COMPLETED | 5 | 0 |
| Withdrawal by Subject | 1 | 0 |
| Lost to Follow-up | 2 | 0 |
| moved to another place | 2 | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| 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. |
| 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. |
| Total | Total of all reporting groups |
Baseline Measures
| Broncho-Vaxom Group | Placebo Group | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
40 | 40 | 80 |
|
Age
[units: participants] |
|||
| <=18 years | 40 | 40 | 80 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
|
Age
[units: years] Mean ± Standard Deviation |
2.51 ± 1.48 | 2.65 ± 1.69 | 2.59 ± 0.59 |
|
Gender
[units: participants] |
|||
| Female | 12 | 13 | 25 |
| Male | 28 | 27 | 55 |
|
Region of Enrollment
[units: participants] |
|||
| Turkey | 40 | 40 | 80 |
Outcome Measures
| 1. Primary: | Mean Rate of Wheezing Attacks [ Time Frame: 12 months ] |
| 2. Secondary: | Mean Duration (in Day) of Wheezing Attacks Per Patient [ Time Frame: 12 months ] |
| 3. Secondary: | Number of Common Cold [ Time Frame: 12 months ] |
| 4. Secondary: | Number of Wheezing Attacks That Required Systemic Steroid Therapy [ Time Frame: 12 months ] |
| 5. Secondary: | Number of Hospitalizations [ Time Frame: 12 months ] |
| 6. Secondary: | Duration of Hospitalization/Per Patient [ Time Frame: 12 months ] |
| 7. Secondary: | Effect of OM-85 BV on Cytokine Levels [ Time Frame: 6 months ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
No
Serious Adverse Events Other Adverse Events
| Time Frame | 6 months |
|---|---|
| Additional Description | 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. |
Frequency Threshold
| Threshold above which other adverse events are reported | 0% |
|---|
Reporting Groups
| Description | |
|---|---|
| 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. |
| 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. |
Other Adverse Events
| Broncho-Vaxom Group | Placebo Group | |
|---|---|---|
| Total, other (not including serious) adverse events | ||
| # participants affected / at risk | 3/35 | 2/40 |
| Gastrointestinal disorders | ||
| diarrhea * 1 | ||
| # participants affected / at risk | 1/35 (2.86%) | 1/40 (2.50%) |
| # events | 1 | 1 |
| abdominal pain * 1 | ||
| # participants affected / at risk | 1/35 (2.86%) | 1/40 (2.50%) |
| # events | 1 | 1 |
| Skin and subcutaneous tissue disorders | ||
| erythema nodosum * 1 | ||
| # participants affected / at risk | 1/35 (2.86%) | 0/40 (0.00%) |
| # events | 1 | 0 |
| * | Events were collected by non-systematic assessment |
|---|---|
| 1 | Term from vocabulary, - |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| All Principal Investigators ARE employed by the organization sponsoring the study. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| 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. |
Results Point of Contact:
Name/Title: Cem Hasan RAZİ
Organization: Kecioren Education and Training Hospital
phone: 090 312 3659000 ext 1139
e-mail: cemrazi2@gmail.com
Organization: Kecioren Education and Training Hospital
phone: 090 312 3659000 ext 1139
e-mail: cemrazi2@gmail.com
No publications provided
| Responsible Party: | Cem Hasan Razi, Kecioren Education and Training Hospital |
| ClinicalTrials.gov Identifier: | NCT00733226 History of Changes |
| Other Study ID Numbers: | B100İEG0110001 - 2860 |
| Study First Received: | August 11, 2008 |
| Results First Received: | December 16, 2009 |
| Last Updated: | December 17, 2011 |
| Health Authority: | Turkey: Ethics Committee Turkey: Ministry of Health |