Experts say inhaled corticosteroid-based relievers must replace outdated SABA-only prescribing, with one respiratory physician saying he believes OTC sales should be phased out.
Overuse of short-acting beta agonists (SABA) to treat asthma is associated with increased risk of asthma-related exacerbations and even death, experts have warned.
The so-called blue puffer has been ousted in favour of inhaled corticosteroids for the treatment of asthma in adolescents and adults, in the newly updated Australian Asthma Handbook released earlier this week.
The National Asthma Council has issued a clear directive that SABA-only treatment should no longer be prescribed or advised for people aged over 12 years with asthma.
Instead of relying on SABAs for symptom relief, the new recommendations endorse anti-inflammatory reliever (AIR)-only therapy or maintenance-and-reliever therapy (MART) as safer and more effective alternatives.
SABA inhalers have been a mainstay of asthma treatment for generations. While effective at easing symptoms, they do not address the underlying airway inflammation that drives asthma pathology.
Professor Peter Wark, a respiratory physician and National Asthma Council Australia Director, told Allergy & Respiratory Republic the move away from SABAs was not particularly new, but the previous iteration of the guidelines allowed this for people with mild asthma.
“For people with mild or very mild asthma, the evidence clearly states that this is not a position that we can any longer keep,” he said.
“That has been the position of a number of other international guideline groups, particularly GINA [the Global Initiative for Asthma] and the BTS [British Thoracic Society]. So we’re in keeping with that.
“The recommendation now is for all people over the age of six to be treated with a regime of at least low-dose inhaled corticosteroids. Now for 12 and above, our recommended first treatment for people, even with mild asthma, is to lead with anti-inflammatory reliever therapy, and that’s budesonide formoterol on an as-needed basis.
“And that is a strong recommendation against the use of treatment with short-acting beta agonists alone. The evidence very strongly indicates that for these individuals, they are at lower risk of exacerbations and the need to use prednisone, they will use less short-acting beta agonist reliever, and they will have better symptom control with this treatment.
“Our alternative is low-dose inhaled corticosteroid, short-acting beta agonist, as it always has been, but our preference is for anti-inflammatory reliever therapy in this group.”
He said he would like to see over-the-counter SABA sales phased out in pharmacies going forward.
“I think that the time for that has long passed. I think it’s encouraging bad treatment for asthma, and it’s encouraging people to not have effective treatment,” said Professor Wark.
“It delays the inevitable, and the people at greatest risk of serious exacerbations are the people that are overusing short-acting beta agonists, many of whom are not engaging with primary care practitioners for lots of reasons, such as cost, availability and convenience.
“Even with subsidised prescriptions, the price signal to just use an as-needed, short-acting beta agonist is so strong.
“If you can go and buy a salbutamol inhaler for $6-8 without the need to go and get a prescription, for a busy individual that’s a very powerful signal against good treatment.”
Professor Wark also highlighted changes to the diagnostic criteria in the updated handbook.
“We are now advocating for the use of exhaled nitric oxide as a potential diagnostic tool for people with asthma [aged] six and above,” he told ARR.
“We still do recommend that people look at reversibility based on spirometry, but we know that the sensitivity for that is low, while the specificity is high.
“So, it’s a good test if it’s positive; it’s not necessarily a good test if it’s negative. And it doesn’t rule out asthma. We are now recommending as an alternative, complementary test to also look at exhaled nitric oxide with a cut-off of 35 parts per billion in children and 40 parts per billion in adults as having acceptable sensitivity and specificity with a consistent clinical history.
“That will also be enough to make a clear diagnosis of asthma. And so, to speed up that diagnostic process, we’re trying to encourage people, where they can, to order both spirometry and exhaled nitric oxide.”
Professor Nick Zwar, GP and chair of the NAC Guidelines Committee told ARR that SABA therapy alone has its risks.
“It’s been shown that you can have an exacerbation, and sometimes that can be quite a severe exacerbation, and your risk of getting that is higher if you’re on SABA alone,” he said.
“We really are also trying to avoid people needing to have courses of oral steroids. So it’s another way of avoiding a course of oral steroid, to be on an anti-inflammatory reliever therapy. So that’s probably the biggest change.
“I think the other one is now we are more explicit that if someone needs continuous therapy, that the preferred pathway is the maintenance and reliever therapy.
“This is where you use the same puffer for everyday use, for maintenance use, and then if you get a flare up you just increase the dose of that for a reliever.
“You don’t need two different puffers, two different devices.”
Clinical Associate Professor Debbie Rigby, pharmacist and NAC Clinical Executive lead, said the evidence was now overwhelming that SABA-only treatment carried risks.
In a webinar this month that coincided with the launch of the updated handbook, she was among the presenters who shared a snapshot of asthma in Australia which showed one in nine Australians report having asthma (2.8 million people).
According to the snapshot, 27% of people aged 40 years and under have poor asthma control, based on the use of reliever medication; and 31% aged 50 years and under had good adherence to their preventer medication.
Professor Rigby said the goals of asthma therapy were to achieve long-term control where patients have few or no symptoms, no sleep disturbances and no impairment of their day-to-day activities.
It was also important to reduce the risk of future exacerbations and hopefully reduce the risk of maintenance oral corticosteroids, “because we know the harm associated with that”, she said.
“In 2023 we had 474 deaths from asthma, and really, with the drugs that we have these days, nobody should be dying from asthma,” she told the webinar.
“We also have over 90% of asthma hospitalisations potentially preventable, and the number of ED presentations is about 150 presentations for asthma every single day.
“And as you can see from the statistics, we know that many, many people do not have good control of their asthma, and that’s partly because they don’t have good adherence to their preventer medicines.
“And sadly, these rates haven’t changed significantly over the last decade or so. So, we have a real opportunity now to improve asthma control.”
The webinar heard that 15 million SABA inhalers were dispensed every year in Australia for asthma and COPD treatment. Over-reliance on SABA could be discovered through asking patients how many cannisters they were using per year.
Three or more SABA reliever cannisters per year were associated with an increased risk of asthma-related exacerbations, while 12 or more were associated with increased risk of death.
“SABA over-reliance is a problem in Australia and indeed worldwide,” said Professor Rigby.
“One of the guide recommendations in the guidelines says as-needed, short-acting beta2 agonists or SABAs alone is inadequate treatment for asthma in adults and adolescents, so no adult or adolescent with confirmed asthma should be taking SABA alone.
“And the reason for this is that we have pretty compelling evidence that SABA-only treatment is associated with a higher risk of severe exacerbations compared with anti-inflammatory reliever therapy only.
“We know that three or more SABA reliever canisters per year increases the risk of exacerbations, and 12 or more, meaning one a month, increase is associated with an increased risk of death.”
Professor Rigby said real world evidence from a community pharmacy study identified that 70% of patients coming into a community pharmacy over a month were defined as over-users of SABAs, and that was defined as twice a week.
Three quarters of patients reported not using their preventer daily, and, “somewhat alarmingly”, 20% of people had not had a formal diagnosis by their GP.
The NAC’s updated recommendations reflect international evidence showing that even patients with mild asthma benefit from inhaled corticosteroid (ICS) exposure. This approach reduces the risk of exacerbations and improves long-term outcomes.
The three-year review was led by a multidisciplinary network of expert primary care and specialist contributors on the NAC’s Guidelines Committee. The new guidelines represent the first major update since 2016.
They position low-dose budesonide-formoterol as the preferred first-line option for adults and adolescents. Patients can take the combination inhaler only when symptoms occur, receiving both rapid symptom relief and anti-inflammatory protection.
Professor Zwar said the goal was to move away from short-term symptom management towards disease-modifying treatment from the very first prescription.
“The common approach was starting patients with mild asthma on SABA as needed. However, this did not treat the underlying inflammation,” he said.
“Starting patients on the new recommendation for low-dose budesonide-formoterol as needed offers a more evidence-based approach to asthma management and reflects the biology of the condition.
“Patients sometimes initially think that an anti-inflammatory reliever doesn’t work as well as their SABA puffer, and we need to help them understand that it is working. The quick action of the long-acting beta agonist gives relief from symptoms, and, also, they are getting an anti-inflammatory effect from the low-dose corticosteroid.”
Evidence shows MART reduces exacerbation rates more effectively than fixed-dose maintenance inhaled corticosteroid-long-acting beta agonist (ICS-LABA) regimens with SABA relievers, while also simplifying treatment for patients.
Professor Zwar told ARR there was still a role for SABA in children with mild asthma and for patients on maintenance therapy of low-dose ICS. This is explained further in the handbook.
An updated website detailing the new changes to the handbook was also launched this week. It provides comprehensive sections on diagnosis, management and treating acute asthma, for adults and adolescents, children aged six to 11 years and children aged one to five years.
“The good thing about the new website is that key stuff that that doctors and other health professionals are looking for is much easier to find,” Professor Zwar said.
He said when prescribing AIR or MART treatment, every patient should be given a Written Asthma Action Plan.
“This clearly outlines what the person is supposed to do and how much medication they should be using and when they should be concerned,” he said.
“If the patient takes action early and they are using a low-dose anti-inflammatory medication, it means that the asthma attack is controlled more quickly, and they are using less reliever medication.
“We also encourage all health professionals to advise patients to carry their anti-inflammatory reliever at all times and use it when they experience difficulty breathing, or before exercise, if needed.”
Professor Wark conceded that there would be challenges in encouraging patients to divert their reliance on salbutamol.
“It’s very hard with a cost signal and a convenience signal that you can just walk in and get a reliever medication, but it is such inadequate treatment for asthma, and we have to give people a viable and effective alternative,” he said.
“Let’s not minimise the difficulties of that. Implementing this is not going to be straightforward.
“And just because we’ve come up with these guidelines which are evidence-based, that doesn’t mean that it’s going to immediately filter through to the community, to practitioners, and, of course, to patients as well.
“This is a conversation that we have to keep having.”
