Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
A database of clinical trials and their results from Australia, New Zealand, and other countries.
account_circle
Log in
to register or update your trial
search
Search for trials
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05857930
Registration number
NCT05857930
Ethics application status
Date submitted
4/05/2023
Date registered
15/05/2023
Date last updated
11/05/2025
Titles & IDs
Public title
A Study to Assess the Efficacy and Safety of Daily OM-85 in Young Children With Recurrent Wheezing
Query!
Scientific title
A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 2 Study to Assess the Efficacy and Safety of Daily OM-85 Treatment vs. Placebo Given in Children Aged 6 Months to 5 Years With Recurrent Wheezing
Query!
Secondary ID [1]
0
0
2024-511083-90-00
Query!
Secondary ID [2]
0
0
BV-2020/09
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Recurrent Wheezing
0
0
Query!
Wheezing Lower Respiratory Illness
0
0
Query!
Condition category
Condition code
Other
0
0
0
0
Query!
Research that is not of generic health relevance and not applicable to specific health categories listed above
Query!
Respiratory
0
0
0
0
Query!
Other respiratory disorders / diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - OM-85
Treatment: Drugs - Placebo
Experimental: OM-85 - Patients will receive OM-85 capsules as a treatment for 6 months and will be under observation for 6 months.
Placebo comparator: Placebo - Patients will receive placebo capsules as a treatment for 6 months and will be under observation for 6 months.
Treatment: Drugs: OM-85
OM-85 capsule (3.5mg) contents will be mixed with adequate quantity of water, fruit juice or milk/formula and orally administered once a day for 6 consecutive months.
Treatment: Drugs: Placebo
Placebo capsule contents will be mixed with adequate quantity of water, fruit juice or milk/formula and orally administered once a day for 6 consecutive months.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Rate of Wheezing/Asthma like episodes (WEs)
Query!
Assessment method [1]
0
0
To assess the efficacy of OM-85 in reducing the rate of WEs compared to placebo during the 6-month Treatment period in children aged 6 months to 5 years with previous recurrent WEs.
Query!
Timepoint [1]
0
0
6 Months
Query!
Secondary outcome [1]
0
0
Rate of severe WEs
Query!
Assessment method [1]
0
0
To assess the efficacy of OM-85 in reducing the rate of severe WEs compared to placebo during the 6-month Treatment period.
Query!
Timepoint [1]
0
0
6 Months
Query!
Secondary outcome [2]
0
0
Number of WE requiring oral corticosteroid (OCS) treatment during 6-month treatment period
Query!
Assessment method [2]
0
0
To assess the efficacy of OM-85 in reducing the use of oral corticosteroids for WEs compared to placebo during the 6-month Treatment period.
Query!
Timepoint [2]
0
0
6 Months
Query!
Secondary outcome [3]
0
0
Number of days with WEs
Query!
Assessment method [3]
0
0
To assess the efficacy of OM-85 to decrease the cumulative number of days with WEs compared to placebo during the 6-month Treatment period.
Query!
Timepoint [3]
0
0
6 Months
Query!
Secondary outcome [4]
0
0
Rate of WEs and severe WEs
Query!
Assessment method [4]
0
0
To assess the efficacy of OM-85 compared to placebo in reducing the rate of WEs and severe WEs during the 6-month Observational period.
Query!
Timepoint [4]
0
0
From Month 6 up to Month 12
Query!
Secondary outcome [5]
0
0
Number of WE requiring OCS treatments during 6-month observational period
Query!
Assessment method [5]
0
0
To assess the efficacy of OM-85 in reducing the use of oral corticosteroids for WEs vs. placebo during the 6-month observational period.
Query!
Timepoint [5]
0
0
From Month 6 up to Month 12
Query!
Secondary outcome [6]
0
0
Duration in days of WEs and severe WEs
Query!
Assessment method [6]
0
0
To assess the efficacy of OM-85 compared to placebo in reducing the duration of WEs and of severe WEs during the 6-month Treatment period and the 6-month Observational period.
Query!
Timepoint [6]
0
0
12 Months
Query!
Secondary outcome [7]
0
0
Time to treatment failure
Query!
Assessment method [7]
0
0
To assess the efficacy of OM-85 compared to placebo to prolong time to treatment failure, during the whole study period.
Query!
Timepoint [7]
0
0
12 Months
Query!
Secondary outcome [8]
0
0
Time to first, second and third WE
Query!
Assessment method [8]
0
0
To assess the efficacy of OM-85 compared to placebo to prolong the time to first, second, and third WE.
Query!
Timepoint [8]
0
0
12 Months
Query!
Secondary outcome [9]
0
0
Number of routine asthma treatment
Query!
Assessment method [9]
0
0
To assess the efficacy of OM-85 compared to placebo to reduce the amount of routine asthma treatment required to control acute WEs during the 6-month treatment period and the 6-month observational period. The number of routine asthma treatment will be assessed.
Query!
Timepoint [9]
0
0
12 Months
Query!
Secondary outcome [10]
0
0
Duration of routine asthma treatment
Query!
Assessment method [10]
0
0
To assess the efficacy of OM-85 compared to placebo to reduce the amount of routine asthma treatment required to control acute WEs during the 6-month treatment period and the 6-month observational period. The duration of routine asthma treatment will be assessed.
Query!
Timepoint [10]
0
0
12 Months
Query!
Secondary outcome [11]
0
0
Percentage of patients with recurrent wheezing
Query!
Assessment method [11]
0
0
To assess the efficacy of OM-85 compared to placebo in reducing the percentage of patients with =1 WEs and =2 WEs during the 6-month treatment period and the 6-month observational period.
Query!
Timepoint [11]
0
0
12 Months
Query!
Secondary outcome [12]
0
0
Number of days with respiratory tract infection (RTIs) symptoms
Query!
Assessment method [12]
0
0
To assess the efficacy of OM-85 compared to placebo in reducing the number of days with RTI symptoms during the 6-month treatment period and the 6-month observational period.
Query!
Timepoint [12]
0
0
12 Months
Query!
Secondary outcome [13]
0
0
Level of severity of RTI symptoms (Absent/Mild/Moderate/Severe)
Query!
Assessment method [13]
0
0
To assess the efficacy of OM-85 compared to placebo in reducing the severity of RTI symptoms during the 6-month treatment period and the 6-month observational period. RTI symptoms severity will be assessed based on the symptom evaluation in the adapted Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K), other relevant symptoms indicative of an RTI (e.g., headache, body aches), and tympanic temperature as recorded by patient's parents or legally authorized representative (LAR). Severity of symptoms will be determined by using the following definitions: child does not have this = absent (no sign/symptom evident); a little bad = mild (sign/symptom clearly present but easily tolerated); bad = moderate (definite awareness of sign/symptom that is bothersome but tolerable); and very bad = severe (sign/symptom that is hard to tolerate and causes interference with activities of daily life and/or sleeping).
Query!
Timepoint [13]
0
0
12 Months
Query!
Secondary outcome [14]
0
0
Number of antibiotic cycles
Query!
Assessment method [14]
0
0
To assess the efficacy of OM-85 compared to placebo in reducing the antibiotics treatment for an RTI during the 6-month treatment period and the 6-month observational period.
Query!
Timepoint [14]
0
0
12 Months
Query!
Secondary outcome [15]
0
0
Number of medical visits
Query!
Assessment method [15]
0
0
To assess the efficacy of OM-85 compared to placebo in reducing the number of medical visits (hospitalizations, visits to emergency rooms, or to a physician/health care provider) due to respiratory events during the 6-month treatment period and the 6-month observational period.
Query!
Timepoint [15]
0
0
12 Months
Query!
Secondary outcome [16]
0
0
Number of days absent from daycare/school
Query!
Assessment method [16]
0
0
To assess the efficacy of OM-85 compared to placebo in reducing the number of days of absence from daycare/school due to respiratory events during the 6-month treatment period and the 6-month observational period.
Query!
Timepoint [16]
0
0
12 Months
Query!
Secondary outcome [17]
0
0
Number of patients with adverse events (AEs)
Query!
Assessment method [17]
0
0
To assess the safety of daily OM-85 treatment compared to placebo in children aged 6 months to 5 years with recurrent WEs during the 6-month treatment period and the 6-month observational period.
Query!
Timepoint [17]
0
0
12 Months
Query!
Secondary outcome [18]
0
0
Number of work days when parents/LAR had to miss work or had their productivity
Query!
Assessment method [18]
0
0
To assess the efficacy of OM-85 compared to placebo in reducing the number of days of absence from daycare/school due to respiratory events during the 6-month treatment period and the 6-month observational period.
Query!
Timepoint [18]
0
0
12 Months
Query!
Eligibility
Key inclusion criteria
Subjects who meet all the following criteria will be included in the study:
* Children of either gender, aged between 6 and 72 months (5 years inclusive).
* Children with recurrent wheezing:
* For ICS/LTRA naïve patients or intermittent users (patients using ICS treatment only during an upper RTI to prevent WE): =2 WEs including at least 1 severe episode (i.e., treated with OCS OR having triggered an ED visit/hospitalization), OR =3 WEs including at least one that triggered an unscheduled physician visit, in the 12 months prior to enrollment.
* For ICS/LTRA daily users: =1 severe WE (i.e., treated with OCS OR having triggered an ED visit/hospitalization) OR =2 WEs including at least one that triggered an unscheduled physician visit, as reported by parents or LAR of subject (i.e., guardians), in the 12 months prior to enrollment, while being on their daily controller therapy.
* Up-to-date vaccination status as per applicable State or country Vaccination Requirements for school/day-care entry.
* Parents or LAR have provided the appropriate written informed consent. Written informed consent must be provided before any study-specific procedures are performed including screening procedures.
Note: If a subject is experiencing respiratory symptoms at time of screening, he/she could only be randomized once symptoms have resolved for at least one week.
Query!
Minimum age
6
Months
Query!
Query!
Maximum age
72
Months
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Known anatomic alterations of the respiratory tract.
* Wheezing documented to be caused by gastroesophageal reflux.
* Other known chronic respiratory diseases (e.g., tuberculosis or cystic fibrosis).
* Any known autoimmune disease.
* Known human immunodeficiency virus (HIV) infection or any known type of congenital or iatrogenic immune deficiency (including immunoglobulin (Ig) A deficiency).
* Known acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal function abnormalities.
* Children born prematurely i.e., before 34 weeks of gestational age.
* Children with an abnormally low or high weight for their age and height, if this would not allow safe completion of the clinical study in the opinion of the investigator.
* Any known neoplasia or malignancy.
* Treatment with the following medications:
* Systemic (intravenous or intramuscular) or OCS (e.g., oral prednisolone) within 4 weeks before study enrollment.
* Previous and/or concomitant immunosuppressants, immunostimulants, or gamma globulins within 6 months before study enrollment.
* Any major surgery within the last 3 months prior to study enrollment or planned during the study duration.
* Known allergy or previous intolerance to investigational drug.
* Any other clinical conditions, which in the opinion of the Investigator, would not allow safe completion of the clinical study.
* Other household members have previously been randomized in this clinical study.
* Inability to comply with the study requested visit schedule (e.g., expected relocation within 12 months of the screening for the study).
* Currently enrolled in or has completed any other investigational device or drug study <30 days prior to screening or receiving other investigational agent(s).
Note: Subjects with past, present, or at risk of COVID-19 should not be excluded from the study.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
20/06/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
30/09/2026
Query!
Actual
Query!
Sample size
Target
288
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
University Hospital Geelong - Barwon Health - Geelong
Query!
Recruitment hospital [2]
0
0
The Royal Childrens Hospital - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
3220 - Geelong
Query!
Recruitment postcode(s) [2]
0
0
3052 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Indiana
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kentucky
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Louisiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Massachusetts
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
New York
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
North Carolina
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Ohio
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Oklahoma
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Tennessee
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Texas
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Wisconsin
Query!
Country [18]
0
0
Hungary
Query!
State/province [18]
0
0
Borsod-Abauj-Zemplen
Query!
Country [19]
0
0
Hungary
Query!
State/province [19]
0
0
Csongrad
Query!
Country [20]
0
0
Poland
Query!
State/province [20]
0
0
Lodzkie
Query!
Country [21]
0
0
Poland
Query!
State/province [21]
0
0
Malopolskie
Query!
Country [22]
0
0
Poland
Query!
State/province [22]
0
0
Podlaskie
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
OM Pharma SA
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study will assess the efficacy and safety of daily OM-85 treatment compared to placebo in children aged 6 months to 5 years with recurrent wheezing
Query!
Trial website
https://clinicaltrials.gov/study/NCT05857930
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Lorenz Lehr
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+41 22 7831459
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05857930
Download to PDF