RecruitingPhase 3ACTRN12620001370998

Assessing the Reduction of Recurrent admissions using OM-85 for the treatment of preschool Wheeze (ARROW): a multi-centre, randomised, double-blind, placebo-controlled trial

Impact of the immunomodulator OM85 on wheeze-associated hospitalisation in preschoolers: a multi-centre, randomised, double-blind, placebo-controlled trial

Sponsor

Deakin University

Enrollment

1,088 participants

Start Date

Apr 1, 2022

Study Type

Interventional

Conditions

recurrent wheeze

Summary

Preschool wheeze is among the most common causes of hospital admission in young children worldwide. Current prevention strategies are ineffective and parents and paediatricians identify developing effective treatments to prevent hospital admission as a research priority. Compelling evidence from animal, laboratory and clinical studies support the hypothesis that OM-85 has the potential to reduce the risk of hospital admission due to preschool wheeze. This trial has been designed and powered to address this question, which is critical to both consumers and the health system.

Eligibility

Sex: Both males and femalesMin Age: 1 YearsMax Age: 6 Yearss

Inclusion Criteria2

All children aged 1 to <6 years who in the preceding 12 months have had: at least one hospital presentation lasting > 6 hours and at least 2 other episodes of wheeze or whistling in the chest on breathing out, lasting >6 hours, associated with laboured breathing.
Parent(s) or legal guardian(s) of the child is able to understand the study requirements and willing to provide informed consent

Exclusion Criteria9

Known adverse reaction or hypersensitivity to bacterial lysates or to any of the excipients in OM-85 in accordance with the composition.
Known anatomic alterations of the respiratory tract.
Chronic respiratory diseases other than preschool wheeze/asthma. These include: cystic fibrosis, chronic suppurative lung disease; and chronic lung disease of prematurity, defined by a persisting oxygen requirement at a corrected gestational age of 40 weeks.
History of malignancy, autoimmune disease, liver or kidney failure. Type 1 diabetes mellitus is not exclusionary.
Treatment with systemic immunosuppressant drugs including methotrexate, cyclosporine or azathioprine within 30 days prior to enrolment in this study. Topical immunosuppressants are not exclusionary.
Treatment with OM-85.
Limited/no access to an internet connection and/or a phone.
Unable to fulfil protocol follow up requirements for > 2 months (e.g., planned overseas travel with limited internet access).
Another participant in the same household is concurrently enrolled in the ARROW Trial.

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Interventions

The aim of this study is to assess the efficacy of OM-85 for prevention of hospital admission in preschool aged children with recurrent wheeze in comparison to placebo. Half the participants will b

The aim of this study is to assess the efficacy of OM-85 for prevention of hospital admission in preschool aged children with recurrent wheeze in comparison to placebo. Half the participants will be given capsules containing OM-85 (Broncho-Vaxom), half will be given a placebo. - the dose administered = 3.5mg daily; - the duration of administration =first 10 days of the calendar month for 12 months; - the mode of administration = oral tablet. Excipients of the capsule include (pregelatinised) corn starch, magnesium stearate, sodium glutamate (E621), mannitol, gelatin, antioxidant: propyl gallate (E310), colour, indigotine (E132). Adherence will be monitors via self reporting in the electronic diaries every 10 days. Participants may be called to continue engagement, to check adverse events, to encourage them to complete the diaries and check on the status of their study capsules.