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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

Titles & IDs
Public title
A Study to Assess the Efficacy and Safety of Daily OM-85 in Young Children With Recurrent Wheezing
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
Secondary ID [1] 0 0
2024-511083-90-00
Secondary ID [2] 0 0
BV-2020/09
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent Wheezing 0 0
Wheezing Lower Respiratory Illness 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of Wheezing/Asthma like episodes (WEs)
Timepoint [1] 0 0
6 Months
Secondary outcome [1] 0 0
Rate of severe WEs
Timepoint [1] 0 0
6 Months
Secondary outcome [2] 0 0
Number of WE requiring oral corticosteroid (OCS) treatment during 6-month treatment period
Timepoint [2] 0 0
6 Months
Secondary outcome [3] 0 0
Number of days with WEs
Timepoint [3] 0 0
6 Months
Secondary outcome [4] 0 0
Rate of WEs and severe WEs
Timepoint [4] 0 0
From Month 6 up to Month 12
Secondary outcome [5] 0 0
Number of WE requiring OCS treatments during 6-month observational period
Timepoint [5] 0 0
From Month 6 up to Month 12
Secondary outcome [6] 0 0
Duration in days of WEs and severe WEs
Timepoint [6] 0 0
12 Months
Secondary outcome [7] 0 0
Time to treatment failure
Timepoint [7] 0 0
12 Months
Secondary outcome [8] 0 0
Time to first, second and third WE
Timepoint [8] 0 0
12 Months
Secondary outcome [9] 0 0
Number of routine asthma treatment
Timepoint [9] 0 0
12 Months
Secondary outcome [10] 0 0
Duration of routine asthma treatment
Timepoint [10] 0 0
12 Months
Secondary outcome [11] 0 0
Percentage of patients with recurrent wheezing
Timepoint [11] 0 0
12 Months
Secondary outcome [12] 0 0
Number of days with respiratory tract infection (RTIs) symptoms
Timepoint [12] 0 0
12 Months
Secondary outcome [13] 0 0
Level of severity of RTI symptoms (Absent/Mild/Moderate/Severe)
Timepoint [13] 0 0
12 Months
Secondary outcome [14] 0 0
Number of antibiotic cycles
Timepoint [14] 0 0
12 Months
Secondary outcome [15] 0 0
Number of medical visits
Timepoint [15] 0 0
12 Months
Secondary outcome [16] 0 0
Number of days absent from daycare/school
Timepoint [16] 0 0
12 Months
Secondary outcome [17] 0 0
Number of patients with adverse events (AEs)
Timepoint [17] 0 0
12 Months
Secondary outcome [18] 0 0
Number of work days when parents/LAR had to miss work or had their productivity
Timepoint [18] 0 0
12 Months

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.
Minimum age
6 Months
Maximum age
72 Months
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
288
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
University Hospital Geelong - Barwon Health - Geelong
Recruitment hospital [2] 0 0
The Royal Childrens Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3220 - Geelong
Recruitment postcode(s) [2] 0 0
3052 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Wisconsin
Country [18] 0 0
Hungary
State/province [18] 0 0
Borsod-Abauj-Zemplen
Country [19] 0 0
Hungary
State/province [19] 0 0
Csongrad
Country [20] 0 0
Poland
State/province [20] 0 0
Lodzkie
Country [21] 0 0
Poland
State/province [21] 0 0
Malopolskie
Country [22] 0 0
Poland
State/province [22] 0 0
Podlaskie

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
OM Pharma SA
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lorenz Lehr
Address 0 0
Country 0 0
Phone 0 0
+41 22 7831459
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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