Preventing asthma exacerbations in children aged 6 to 12 years with atopic asthma using a winter only treatment with OM-85
- Conditions
- AsthmaAtopyRespiratory - Asthma
- Registration Number
- ACTRN12614000062628
- Lead Sponsor
- The University of Queensland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 19
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The mean number of lower respiratory events per patient over the treatment period.<br><br>Lower respiratory events are defined as a wheezy lower respiratory infection lasting two or more days requiring additional asthma medication. Events will be recorded via patient daily diary.[- Two weeks after the last dose of treatment (5 months after start of treatment), and<br>- Three months after last dose of treatment]
- Secondary Outcome Measures
Name Time Method