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

A phase 3, multi-centre, double-blind, randomised, placebo-controlled study testing the efficacy of winter only treatment with omalizumab for the reduction of asthma exacerbations in children aged 6 to 15 years.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001106921

Acronym

RELAX

Enrollment

Registered

2011-10-24

Start date

2012-03-28

Completion date

2014-06-16

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

Background Asthma is a huge social and economic burden on our community. Acute exacerbations of asthma are linked with worse lung outcomes for children. In school aged children a risk for acute exacerbations include viral infections, which occur mainly in winter, and allergy. A drug called omalizumab may help prevent acute exacerbations by damping the allergy response. Aim We want to see if omalizumab will decrease the number of children with asthma having an acute exacerbation.

Interventions

Omalizumab, based on body weight and serum IgE, by subcutaneous injection each two to four weeks for five months over the Australian winter viral season (April to September). The following paediatric dosing table applies: A dose of 75mg each four weeks is administered for: IgE level 30-100IU/ml and weight 20-40kg. A dose of 150mg is administered each four weeks for: IgE level 30-100IU/ml and weight 40-90kg; IgE level 100-200IU/ml and weight 20-40kg; IgE level 200-300IU/ml and weight 20-30kg. A dose of 225 is administered each four weeks for: IgE level 200-300IU/ml and weight 30-40kg; IgE level 300-400IU/ml and weight 20-30kg; IgE level 400-500IU/ml and weight 20-25kg. A dose of 300mg is administered each four weeks for: IgE level 30-100IU/ml and weight 90-150kg; IgE level 100-200IU/ml and weight 40-90kg; IgE level 200-300IU/ml and weight 40-60kg; IgE level 300-400IU/ml and weight 30-40kg; IgE level 400-500IU/ml and weight 25-30kg; IgE level 500-600IU/ml and weight 20-30kg; IgE level over 600IU/ml and weight 20-25kg. A dose of 225mg is administered each two weeks for IgE level 700-1100IU/ml and weight 20-25kg; IgE level 700-900 and weight 25-30kg; IgE level 400-700 and weight 30-40kg; IgE level 300-500 and 40-50kg; IgE level 300-400 and weight 50-60kg; IgE level 200-400 and weight 60-70kg; IgE level 200-300 and weight 70-90kg; IgE level 100-200 and weight 90-125kg. A dose of 300mg is administered each two weeks for IgE level 1100-1300 and weight 20-25kg; IgE level 900-1200 and weight 25-30kg; IgE level 700-900 and weight 30-40kg; IgE level 500-700 and weight 40-50kg; IgE level 400-600 and weight 50-60kg; IgE level 400-500 and weight 60-70kg; IgE level 300-400 and weight 70-90kg; IgE level 200-300 and weight 90-125kg; IgE level 100-200 and weight 125-150kg. A dose of 375mg is administered each two weeks for IgE level 1200-1300 and weight 25-30kg; IgE level 900-1100 and weight 30-40kg; IgE level 700-900 and weight 40-50kg; IgE level 600-700 and weight 50-60kg; IgE level 500-600 and weight 60-70kg; IgE level 400-500 and weight 70-90kg; IgE level 200-300 and weight 125-150kg. Drug is administered to the participant by a study doctor who will also record the dose given to measure adherence.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

6 Years to 15 Years

Healthy volunteers

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.

Outcome results