Could Combo Asthma Inhalers Go OTC?

Proposal for combination asthma inhalers to be downscheduled to Pharmacist Only with Appendix M controls for ‘as needed’ use.

A request has been made for the TGA to downschedule budesonide-formoterol fixed dose combination (FDC) inhalers to Schedule 3, for use as an anti-inflammatory reliever in people aged 12 years and over who have diagnosed asthma.

The proposed amendment was published on Wednesday, the same day as the launch of the new National Asthma Handbook, which now outlines as-needed low-dose budesonide-formoterol, taken for relief of symptoms, as a treatment alternative to daily maintenance low-dose inhaled corticosteroid preventer for mild asthma.

According to the National Asthma Council Australia, the new recommendation is supported by “strong evidence” from four randomised controlled trials showing combination inhalers not only provide immediate symptom relief, but also reduce the risk of severe flare ups by two-thirds compared with using short-acting relievers alone.

Reduction in risk of severe flare-ups was similar to, or better, than with a daily maintenance low-dose inhaled corticosteroid.

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Source:, viewed 28 August 2020.


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