Preventing asthma exacerbations in children aged 6 to 12 years with atopic asthma using a winter only treatment with OM-85

A phase 3, multi-centre, double blind, randomised, placebo-controlled study testing the efficacy of winter only treatment with OM-85 for the reduction of lower respiratory events in atopic children with asthma aged 6 to 12 years

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000062628

Acronym

OM Child

Enrollment

Registered

2014-01-20

Start date

2014-04-01

Completion date

2014-05-07

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Asthma imposes a huge social and economic burden on our community, accounting for approximately 1.4% of the total expenditure on health in Australia. Major risk factors for exacerbations include previous exacerbations, young age, poorly controlled asthma, and, in particular, viral respiratory infections. Viral induced exacerbations account for between 80 to 85% of all asthma exacerbations, with the most common viruses including rhinovirus, respiratory syncytial virus, human metapneumovirus and the influenza virus. The primary aim of this study is to prevent lower respiratory tract infections over the treatment period using a novel bacterial-derived immunostimulant OM85. OM85 has bacterial lysates of strains frequently encountered in respiratory infections. OM85 BV reduces the susceptibility to suffer from recurrent respiratory infections by priming the immune system. This will help in preventing and reducing the respiratory symptoms to better control asthma in children and reduce severe exacerbations of asthma in children. Lower respiratory events are defined as a wheezy lower respiratory infection lasting three or more days requiring additional asthma medication.

Interventions

Drug Substance Name: OM-85 Drug Product Name: Broncho-Vaxom Dose: 3.5mg daily Duration: 10 days followed by 20 days no treatment for 5 months beginning in March/April Mode of administration: Oral Adherence will be measured by return of empty and full drug blister packs.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

6 Years to 12 Years

Healthy volunteers

Inclusion criteria

Children of either sex, aged 6 to younger than 12 years, with current asthma; At least one moderate or severe exacerbation of asthma, as defined by the ATS/ERS statement on asthma control and exacerbation, in the past 12 months; A C-ACT score of less than or equal to 19; Positive skin prick test to either mould, house dust mite or cat; Participants who, in the opinion of the site investigator, are able to comply with the protocol for its duration; Written informed consent signed and dated by parent/legal guardian according to local regulations.

Exclusion criteria

Children who has previously received OM-85 in the past 3 months; If female and currently pregnant, breastfeeding or of child-bearing potential without reliable contraceptive methods; Participation in another randomized controlled trial within the 3 months preceding inclusion in this study; A significant medical disease or condition other than asthma that is likely to interfere with the child’s ability to complete the entire protocol.

Outcome results