The clinical place of triple therapy FDC inhalers in the management of severe asthma is becoming more established. As a result, the PBS have expanded the treatment options for severe asthma that don’t require specialist referral.

In asthma, there is significant non-adherence to medicines. This could be due to the difficulty of following different treatment schedules or using multiple inhalers. Triple therapy FDC inhalers may improve treatment adherence by reducing the number of inhaler devices needed for maintenance treatment, with fewer instructions and similar dosing schedules.13

2022 Australian Asthma Handbook Version 2.2 guidelines for severe asthma

The guidelines recommend that pharmacological management of asthma involve stepping up (by increasing the dose or adding to the treatment regimen) when good control is not achieved. Before considering stepping up, check that:1

  • any symptoms are related to asthma
  • the inhaler technique is correct
  • adherence is adequate.

If an adult with confirmed severe asthma continues to frequently experience symptoms or flare-ups despite optimised inhaler techniques and adherence and treatment of comorbidities, a trial of add-on treatment with a LAMA or montelukast (a leukotriene receptor antagonist) can be considered before referring for specialist assessment for monoclonal antibody therapy.1

Montelukast is not PBS-listed for severe asthma.14 There is little evidence to support its use as add-on treatment for severe asthma.1

LAMAs (as a single inhaler added to a ICS + LABA FDC inhaler or part of a triple therapy FDC inhaler) are listed as options in the current guidelines.1 Explicit guidance of triple therapy FDC inhalers will be added to version 3.0 of the guidelines.

See the Australian Asthma Handbook for more information on severe asthma in adults and adolescents.

Find out more about using a systemic approach to assessing patients with difficult-to-treat and severe asthma. This resource was developed by NPS MedicineWise for health professionals.

2021 GINA global strategy

In 2021, GINA (Global Initiative for Asthma) updated the global pharmacological management strategy for patients with severe asthma. GINA expanded the treatment options by including triple therapy FDC inhalers in the previous recommendations for adding tiotropium.2

Severe asthma should be managed under specialist care or at a severe asthma clinic if possible. The clinical or inflammatory phenotype should be assessed, as this may guide the selection of treatment.2

If asthma is not well controlled with medium- or high-dose ICS + LABA, a LAMA may be prescribed as a treatment option:2

  • as an add-on in a separate inhaler for patients aged 6 years and older (tiotropium)
  • in a triple therapy FDC inhaler for patients aged 18 years and older (indacaterol with glycopyrronium and mometasone; fluticasone with umeclidinium and vilanterol; beclometasone with formoterol and glycopyrronium).

Clinical evidence

The evidence for the recommendations from GINA is based on data from several clinical trials conducted for the triple therapy FDC inhalers. The studies found that adding a LAMA to ICS + LABA modestly improves lung function compared to ICS + LABA.15-18 In one study, add-on LAMA modestly increased the time to severe exacerbation requiring oral corticosteroids.16

Triple therapy FDC inhalers are a safe and effective therapeutic alternative for patients with poorly controlled asthma despite ICS + LABA treatment.13,19,20

A 2021 systemic review and meta-analysis investigated asthma outcomes associated with triple therapy FDC inhalers compared to ICS + LABA. The authors concluded that among adults with moderate-to-severe asthma, triple therapy FDC inhalers were significantly associated with fewer asthma exacerbations and modest improvements in asthma control, compared to those with dual therapy.20

Practical implications

Comparing clinical efficacy and safety of treatment options

There are no clinically meaningful differences in efficacy and safety between that indacaterol with glycopyrronium and mometasone (Enerzair Breezhaler) and ICS + LABA with tiotropium as an add-on when used for the treatment of severe asthma.12

The PBAC has recommended that indacaterol with glycopyrronium and mometasone (Enerzair Breezhaler) and fluticasone with umeclidinium and vilanterol (Trelegy Ellipta) should be treated as interchangeable on an individual patient basis.21 Please note that interchangeability in this context is different to ‘a’ flagging and brand substitution is not permitted at the point of dispensing.

Indacaterol with glycopyrronium and mometasone (Enerzair Breezhaler) is one of the first inhalers PBS listed for asthma and is the only triple therapy FDC inhaler that requires capsules to be loaded prior to use.9,10 For many patients, this would be a new inhaler technique.12

Fluticasone with umeclidinium and vilanterol (Trelegy Ellipta) is a dry powder inhalation (DPI) device (Ellipta), which has a single-step activation procedure.21

Educating patients about the purpose of their medicine and its correct use is important to ensure they gain the greatest benefit from their treatment.13

Adherence and inhaler technique

Several patient-related factors, such as adherence, need to be considered carefully. The optimum place for triple therapy FDC inhalers within treatment guidelines must be established.13

Adherence rates are often significantly better in patients using a single inhaler than in patients using multiple inhalers.22 At the same time, a single FDC inhaler may reduce the flexibility to adjust the dose of each individual medicine, although some triple therapy FDC inhalers are available at different doses to provide added flexibility.5,13

Use of a single inhaler device may also enable step-up from ICS + LABA therapy in the same device, if required.15 Currently, indacaterol with glycopyrronium and mometasone (Enerzair Breezhaler) is PBS-listed for two different strengths,5 while fluticasone with umeclidinium and vilanterol (Trelegy Ellipta) is PBS-listed for asthma for the high dose only.21

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