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Professor Helen Reddel
TGA indications for Symbicort Turbuhaler 200/6 and Rapihaler 100/3 have been extended to include the as-needed management of mild asthma in adults and adolescents from the age of 12 years.
The change is supported by growing evidence and international guidance, as reported in the limbic earlier this year, that preventer not reliever-only medications should be the foundation of asthma management even in mild disease.
However the PBAC has yet to make positive recommendations for PBS listing – a submission was rejected in July and will be reconsidered at the November meeting – and the changes have yet to be incorporated into national asthma guidelines.
The announcement of the new indications for budesonide and formoterol coincides with a New Zealand study of as-needed use of the ICS/LABA combination versus maintenance therapy with budesonide and as-needed terbutaline.
The PRACTICAL study, published in The Lancet, randomised 885 adults with mild to moderate asthma to one of the treatment arms for 52 weeks.
It found budesonide-formoterol reliever therapy resulted in fewer severe exacerbations, fewer severe exacerbations requiring an ED visit or hospital admission, and a longer time to a first severe exacerbation than maintenance budesonide plus as-needed terbutaline.
“The timing of inhaled corticosteroid administration is probably a more important determinant of efficacy than the total dose, and a symptom-driven increase in the dose of inhaled corticosteroid in worsening asthma might lead to resolution of an exacerbation before it becomes severe enough for the patient to seek medical review,” the study authors said.
Professor Helen Reddel, from the Woolcock Institute of Medical Research and a co-investigator on the study, highlighted the inclusion of inflammatory markers in the study.