Phase 4
Completed N=80
Effect of OM-85 BV on Wheezing Related Morbidity in Children With Recurrent Wheezing
Source: ClinicalTrials.gov NCT00733226 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcomePrimary: Mean Rate of Wheezing Attacks — 3.57; 5.72 wheezing attacks/per patient — p=0.05
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Rate of Wheezing Attacks |
3.57; 5.72 | 0.05 |
| SECONDARY Mean Duration (in Day) of Wheezing Attacks Per Patient |
5.57; 7.66 | <0.001 sig |
| SECONDARY Number of Common Cold |
3.51; 5.62 | <0.001 sig |
| SECONDARY Number of Wheezing Attacks That Required Systemic Steroid Therapy |
0.57; 0.90 | 0.110 |
| SECONDARY Number of Hospitalizations |
0.14; 0.40 | 0.195 |
| SECONDARY Duration of Hospitalization/Per Patient |
0.82; 2.02 | 0.452 |
| SECONDARY Effect of OM-85 BV on Cytokine Levels |
— | — |
Eligibility Criteria
Inclusion Criteria
- Children with recurrent wheezing who had at least 3 wheezing attacks in the last 6 months
- Children with asthma who had at least 3 wheezing attacks in the last 6 months
Exclusion Criteria
- Chronic lung disease
- Immun deficiency
- Malabsorption
- Anatomic abnormalities of the respiratory tract
- Gastroesophageal reflux disease
Data sourced from ClinicalTrials.gov (NCT00733226). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.