Trial Outcomes & Findings for Effect of OM-85 BV on Wheezing Related Morbidity in Children With Recurrent Wheezing (NCT NCT00733226)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

80 participants

Primary outcome timeframe

12 months

Results posted on

2014-07-16

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	40	40
Overall Study COMPLETED	35	40
Overall Study NOT COMPLETED	5	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	2	0
Overall Study moved to another place	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Broncho-Vaxom Group n=40 Participants 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 n=40 Participants 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 n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	2.51 years STANDARD_DEVIATION 1.48 • n=5 Participants	2.65 years STANDARD_DEVIATION 1.69 • n=7 Participants	2.59 years STANDARD_DEVIATION 0.59 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	27 Participants n=7 Participants	55 Participants n=5 Participants
Region of Enrollment Turkey	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

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.

Outcome measures

Outcome measures
Measure	Broncho-Vaxom Group n=35 Participants 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 n=40 Participants 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.
Mean Rate of Wheezing Attacks	3.57 wheezing attacks/per patient Standard Error 1.61	5.72 wheezing attacks/per patient Standard Error 2.72

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Outcome measures
Measure	Broncho-Vaxom Group n=35 Participants 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 n=40 Participants 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.
Mean Duration (in Day) of Wheezing Attacks Per Patient	5.57 day/per patient Standard Error 0.35	7.66 day/per patient Standard Error 0.33

SECONDARY outcome

Timeframe: 12 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.

Outcome measures

Outcome measures
Measure	Broncho-Vaxom Group n=35 Participants 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 n=40 Participants 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.
Number of Common Cold	3.51 common cold/per patients Standard Error 0.26	5.62 common cold/per patients Standard Error 0.31

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Outcome measures
Measure	Broncho-Vaxom Group n=35 Participants 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 n=40 Participants 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.
Number of Wheezing Attacks That Required Systemic Steroid Therapy	0.57 wheezing attacks/per patient Standard Error 0.14	0.90 wheezing attacks/per patient Standard Error 0.16

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Outcome measures
Measure	Broncho-Vaxom Group n=35 Participants 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 n=40 Participants 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.
Number of Hospitalizations	0.14 hospitalization/per patient Standard Error 0.05	0.40 hospitalization/per patient Standard Error 0.12

SECONDARY outcome

Timeframe: 12 months

Over the 12 months of the study we calculated mean duration of hospitalization/per patients.

Outcome measures

Outcome measures
Measure	Broncho-Vaxom Group n=35 Participants 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 n=40 Participants 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.
Duration of Hospitalization/Per Patient	0.82 day/per patient Standard Error 0.35	2.02 day/per patient Standard Error 0.71

SECONDARY outcome

Timeframe: 6 months

Cytokine levels were not measured during the trial because of unavailability of laboratory resources.

Outcome measures

Outcome data not reported

Adverse Events

Broncho-Vaxom Group

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Broncho-Vaxom Group n=35 participants at risk 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 n=40 participants at risk 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.
Gastrointestinal disorders diarrhea	2.9% 1/35 • Number of events 1 • 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.	2.5% 1/40 • Number of events 1 • 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.
Gastrointestinal disorders abdominal pain	2.9% 1/35 • Number of events 1 • 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.	2.5% 1/40 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders erythema nodosum	2.9% 1/35 • Number of events 1 • 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.	0.00% 0/40 • 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.

Additional Information

Cem Hasan RAZİ

Kecioren Education and Training Hospital

Phone: 090 312 3659000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place