Winter-only treatment with omalizumab to prevent asthma exacerbations in childre

Phase 3

Completed

• Conditions: Asthma; Respiratory - Asthma

• Registration Number: ACTRN12611001106921
• Lead Sponsor: niversity of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1. Children of either sex, aged 6 to 15 years, with current asthma;
2. Admission to a hospital emergency department in the previous winter season for acute exacerbation of asthma, as defined by the ATS/ERS statement on asthma control and exacerbation;
3. Atopy;
4. Atopic family history;
5. Participants who, in the opinion of the site investigator, are able to comply with the protocol for its duration;
6. Written informed consent signed and dated by parent/legal guardian according to local regulations.

Exclusion Criteria

1. Hypersensitivity to omalizumab 2. Treatment with omalizumab within 30 days prior to screening 3. Prolonged high dose oral steroids 4. Participation in another randomised controlled trial within the 3 months preceding inclusion in this study 5. 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
Proportion of children with acute asthma exacerbations during treatment period. Exacerbations are defined by the ATS/ERS statement on asthma control and exacerbations, namely: use of steriods (recorded in the concomitant medications) and hospitalisation (recorded in unscheduled events and hospital log).[1.4 years (1 year 4 months) after intervention commencement]

Secondary Outcome Measures

Name	Time	Method
Proportion of viral respiratory infections that result in lower airway symptoms during the treatment period. Presence of upper and lower respiratory tract infection symptoms will be recorded in a patient diary. Detection and identification of virus will be determined using PCR on nasal washes (collected at every clinic visit) and on nasal swabs (collected by study staff at unscheduled visits if possible and by parents during periods of lower respiratory tract infections).[1.4 years (1 year 4 months) after intervention commencement];Lung function and airway responsiveness over the follow up period. Lung function will be measured by spirometry. Airway responsiveness will be measured by methacholine challenge testing.[1.4 years (1 year 4 months) after intervention commencement]