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Effect of OM-85 BV on Wheezing Related Morbidity in Children With Recurrent Wheezing

This study has been completed.
Sponsor:
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
History of Changes
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
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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
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  Outcome Measures
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1.  Primary:   Mean Rate of Wheezing Attacks   [ Time Frame: 12 months ]
  Show Outcome Measure 1

2.  Secondary:   Mean Duration (in Day) of Wheezing Attacks Per Patient   [ Time Frame: 12 months ]
  Show Outcome Measure 2

3.  Secondary:   Number of Common Cold   [ Time Frame: 12 months ]
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4.  Secondary:   Number of Wheezing Attacks That Required Systemic Steroid Therapy   [ Time Frame: 12 months ]
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5.  Secondary:   Number of Hospitalizations   [ Time Frame: 12 months ]
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6.  Secondary:   Duration of Hospitalization/Per Patient   [ Time Frame: 12 months ]
  Show Outcome Measure 6

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
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  Other Adverse Events
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  More Information
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Certain Agreements:  
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


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