None listed
Conditions
Brief summary
Double-blind, randomized, placebo-controlled, clinical trial with the primary objective to determine the efficacy of omalizumab given to children aged 6-12 years during an acute asthma exacerbation to prevent asthma exacerbations in the subsequent six months. Subjects include male and female children aged 6-12 years presenting to Princess Margaret Hospital for Children (PMH) Emergency Department with moderate to severe acute asthma. The ‘treatment’ group (n=64) will receive one dose of omalizumab at the enrolment visit (Visit 1). The ‘placebo’ group (n=64) will receive one dose of a placebo at the enrolment visit (Visit 1). However, in accordance with the dosing table (described in the Xolair (Registered Trademark) (Omalizumab) Product Information Sheet), each participant with sufficient body weight (kg) and total IgE levels to require a second dose of Omalizumab, will need to have a second dose of either Omalizumab or placebo two weeks later. The treatment drug, omalizumab, (or placebo) will be administered at least 12 hours after the patient presents to hospital, at the enrolment visit and following treatment, the patient will be monitored for a minimum of two hours by an experienced paediatrician. All children will also receive standard asthma therapy according to the PMH Clinical Practice Guidelines. This study consists of 3-4 visits over six months (including the first enrolment and treatment visit) and 1 follow-up telephone interview at 12 months.
Interventions
anti-IgE antibody, omalizumab.
The dose of omalizumab to be administered to each subject will be calculated using the subject’s baseline total serum or plasma IgE levels (IU/ml) plus the subject’s weight (kg) in accordance with the dosing table (described in the Xolair (Registered Trademark) (Omalizumab) Product Information Sheet). The Product Information Sheet is listed under Xolair (Registered Trademark) on the the Health Care Professionals page in the following website
https://www.novartis.c
anti-IgE antibody, omalizumab. The dose of omalizumab to be administered to each subject will be calculated using the subject’s baseline total serum or plasma IgE levels (IU/ml) plus the subject’s weight (kg) in accordance with the dosing table (described in the Xolair (Registered Trademark) (Omalizumab) Product Information Sheet). The Product Information Sheet is listed under Xolair (Registered Trademark) on the the Health Care Professionals page in the following website https://www.novartis.com.au/products/healthcare-professionals The dose will be given as a subcutaneous (SC) injection. A single dose of omalizumab will be given. However, in accordance with the dosing table, each participant with sufficient body weight (kg) and total IgE levels to require a second dose of Omalizumab, will need their second dose of either Omalizumab or placebo to be given two weeks later. The treatment drug, omalizumab, (or placebo) will be administered at least 12 hours after the patient presents to hospital, at the enrolment visit. Treatment will be given in the hospital, so adherence will be monitored by the person administering the treatment
Sponsors
The University of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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.
Outcome results
None listed