NCT00733226

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_4 asthma

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2008

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

August 16, 2010

Completed
Last Updated

July 16, 2014

Status Verified

July 1, 2014

Enrollment Period

1.1 years

First QC Date

August 11, 2008

Results QC Date

December 16, 2009

Last Update Submit

July 4, 2014

Conditions

Asthma

Keywords

wheezingasthmachildhoodOM-85 BVBroncho-Vaxom

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Mean Duration (in Day) of Wheezing Attacks Per Patient

    12 months

  • Number of Common Cold

    12 months

  • Number of Wheezing Attacks That Required Systemic Steroid Therapy

    12 months

  • Number of Hospitalizations

    12 months

  • Duration of Hospitalization/Per Patient

    12 months

  • +1 more secondary outcomes

Study Arms (2)

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.

Drug: OM-85 BV (Broncho-Vaxom)

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.

Drug: OM-85 BV (placebo)

Interventions

OM-85 BV (Broncho-Vaxom)DRUG

3.5 mg capsule, 1 capsule per day for first 10 day of the month, for 3 months

Also known as: Bronchovaxom 3.5 mg capsule
1 Broncho-Vaxom
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

Also known as: Bronchovaxom 3.5 mg placebo capsule
2 (Placebo OM-85 BV)

Eligibility Criteria

Age6 Months - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Chronic lung disease
  • Immun deficiency
  • Malabsorption
  • Anatomic abnormalities of the respiratory tract
  • Gastroesophageal reflux disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kecioren Education and Training Hospital

Ankara, Kec.oren, 06380, Turkey (Türkiye)

Location

Keçiören Education and Training Hospital

Ankara, Keçiören, 06380, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 20920766BACKGROUND

MeSH Terms

Conditions

AsthmaRespiratory Sounds

Interventions

Broncho-Vaxom

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

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

Title
Cem Hasan RAZİ
Organization
Kecioren Education and Training Hospital
cemrazi2@gmail.com
090 312 3659000

Study Officials

  • C H RAZI, MD

    Kecioren Education and Training Hospital

    STUDY DIRECTOR

  • C H Razi, MD

    Kecioren Education and Training Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 11, 2008

First Posted

August 13, 2008

Study Start

August 1, 2007

Primary Completion

September 1, 2008

Study Completion

October 1, 2008

Last Updated

July 16, 2014

Results First Posted

August 16, 2010

Record last verified: 2014-07

Locations

TU(2)