GINA update offers two-track approach to ICS-formoterol in asthma

Professor Helen Reddel

Professor Helen Reddel, GINA Science Committee Chair

An update of the Global Strategy for Asthma Management and Prevention has adopted a two-track approach for treatment of adults and adolescents.

In the report from the Global Initiative for Asthma (GINA), Track 1 features low dose combination ICS-formoterol as the reliever and is the preferred treatment approach across the spectrum of asthma severity because it reduces the risk of exacerbations.

Track 2 recognises SABA as the reliever for patients where Track 1 is either not possible or preferred by patients with no exacerbations on their current controller ICS therapy.

Chair of the GINA Science Committee Professor Helen Reddel told the limbic their aim was to make it clear that using as-needed ICS-formoterol as the reliever was the preferred approach based on evidence from multiple studies.

However the report recognised that there were some situations in which Track 2 might be more appropriate.

“In many low and middle income countries, ICS-formoterol is not available. GINA is a global strategy so its recommendations need to take into account different health systems and different medication access.”

“And patients may prefer to stay on the current treatment. Patient preference is something we should always take into account because if you try and enforce a particular treatment on them and they don’t want to do it, well … they just won’t.”

“So in clinical practice, if someone is stable with no exacerbations and no exacerbation risk factors, and they are comfortable with their medication, and I think they are going to keep on taking it, then I don’t think there is a particular reason to change.”

Professor Reddel, from the Woolcock Institute of Medical Research, said clinicians should however look for opportunities to change patients from a high dose ICS-LABA to maintenance and reliever therapy (MART) because the same benefit was achievable with a lower ICS dose.

“As clinicians, what we need to be aware of is making sure that we have found the minimum effective dose for each patient, in combination with an action plan. Some people will settle on a regular treatment that is higher than it needs to be and we should always try to down titrate if they are stable.”

Triple therapy

In another change to the Strategy, Step 5 recommendations for add-on LAMA have been expanded to include combination ICS-LABA-LAMA, if asthma is persistently uncontrolled despite medium or high dose ICS-LABA.

However the report notes the evidence shows while adding a LAMA to medium or high dose ICS-LABA modestly improves lung function, it does not improve symptoms.

“The studies of add-on LAMAs usually have lung function as the primary outcome measure, or a co-primary outcome, because of regulatory requirements relating to bronchodilators. However, improved lung function does not necessarily translate to clinical benefit for the patient,” Professor Reddel said.

“I think it’s curious that you can get these changes in lung function fairly consistently between the studies but really there is no significant impact on symptoms.”

She stressed that exacerbations were more likely to be reduced by an adequate dose of ICS than by adding a LAMA.

“In my clinic, I would add a LAMA for patients with persistent dyspnea in the hope that they will be one of the ones who do get symptom improvement. I don’t continue it then if they don’t improve.”

Blood eosinophils

The report has also incorporated new evidence for an existing recommendation when assessing severe asthma patients’ eligibility for a biologic therapy.

The recommendation is to repeat blood eosinophils if they are low at first assessment.

“We already had a recommendation about repeating it but now there is an additional study to support that recommendation, which showed that 65% of patients on medium or high dose ICS-LABA shifted their eosinophil category over a 12-month period.”

Professor Reddel stressed there was no need for inflammatory phenotyping in order to prescribe as-needed ICS-formoterol in mild asthma, as its benefits compared to either maintenance ICS or as-needed SABA were see in patients who had either low or high FeNO or blood eosinophils at baseline.

“It’s really very important that the advantage of inflammatory phenotyping is in patients with moderate to severe asthma,” she said.


A comprehensive section on COVID-19 and asthma reinforced the message that people with well-controlled asthma are not at increased risk of COVID-19 infection, severe COVID-19 disease or COVID-19-related death.

However evidence had shown that recent oral corticosteroid use, indicating recently unstable or severe asthma, was a risk factor for death from COVID-19. Therefore, patients should have a written asthma action plan and be encouraged to continue taking their prescribed medications.

The report also recommended COVID-19 vaccination for people with asthma.

Vaccination should be timed at least 14 days from other vaccinations such as influenza.

GINA also recommended that in people with severe asthma, the COVID-19 vaccination should not occur on the same day as biologic therapy for asthma, so that any adverse effects of either treatment could be distinguished.


Professor Reddel said another change in the updated report is that MART with a very low dose ICS-formoterol has been added to the treatment figure for children 6-11 years.

“We had actually recommended it in the text many years ago on the basis of the one study that has been done in children of that age. But it wasn’t in the treatment figure itself because in the past, up until 2018, we didn’t include off-label recommendations in the treatment figure.”

She said a change in policy in 2018 saw the addition of other off-label treatments such as macrolides to treatment figures but MART in children had been overlooked until now.

“In Australia, maintenance and reliever therapy isn’t approved for children but the evidence in the Bisgaard study is quite compelling for this being a strategy that should be considered in future.”

She said the paediatric options for asthma treatments in Australia were fairly limited – a concern to paediatric specialists.

Already a member?

Login to keep reading.

Email me a login link

© 2023 the limbic