A clinical trial in children presenting to hospital with an asthma attack, to compare the effectiveness of giving the additional treatment of anti-immunoglobulin E antibody or nothing on the time until their next asthma attack.
- Conditions
- asthma exacerbationsRespiratory - Asthma
- Registration Number
- ACTRN12616000977471
- Lead Sponsor
- The University of Western Australia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 128
1.Male or female children 6-12 years of age presenting to PMH ED with a diagnosis of either acute asthma or asthma exacerbation by the treating physician.
2.An acute asthma severity score of moderate or severe as defined by Qureshi, F. et al. NEJM (1998) 339:1030-5.
3.Admission to hospital with acute wheeze or asthma at least once in the previous year.
4.Parent(s) or legal guardian(s) of the child is able to understand the study requirements and willing to provide informed consent
A child who meets any of the following criteria will be excluded from the study:
1.Known (or evidence of) chronic underlying condition (other than asthma)
2.Known hypersensitivity to omalizumab or other anti-IgE drugs
3.History of a previous doctor diagnosis of anaphylaxis
4.At high risk of chronic helminth infection
5.History of malignancy
6.History of a prior diagnosis with cardiovascular disease or an arterial thromboembolic event
7.Treatment with immunosuppressant drugs including methotrexate, cyclosporine or azathioprine within 30 days prior to enrolment in this study
8.Treatment with omalizumab within 6 months prior to enrolment in this study
9.Participation in another randomized control trial within the 3 months preceding enrolment in this study
10.Any clinically relevant abnormal findings in physical examination and/or vital signs at Visit 1, which, in the opinion of the investigator, may deem the child unsuitable for the study.
11.Pregnancy, breast-feeding or planned pregnancy during the study. Female participants who are fertile (i.e. have reached menarche) will undergo a pregnancy test by urine dipstick.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time (number of days) to next asthma exacerbation in the subsequent six months<br>This will be assessed by the review of medical records and diary records completed by the parents.[Six months post recruitment at presentation to hospital with an asthma exacerbation]
- Secondary Outcome Measures
Name Time Method