The most fundamental change in asthma management in 30 years?

To the Editor:

We would like to raise our considerable concern regarding a potential major change in the management of exacerbations of asthma which is soon to be discussed in the European Union (EU). The Global Initiative for Asthma (GINA) has recently changed their recommendation regarding management of patients with mild asthma. Instead of using only short-acting β₂-agonist (SABA) as needed, GINA suggests that all patients should also be using inhaled corticosteroids (ICS) simultaneously. This was based on a few studies that have used “as needed” ICS/long-acting β₂-agonist (LABA) for acute asthma. A group of authors has hailed this change as “the most fundamental change in asthma management in 30 years” and explained, in detail, the reasons for the change in an article recently published in the European Respiratory Journal [1].

Almost all data on as-needed ICS/LABA for asthma exacerbations were obtained using a dry-powder inhaler (DPI) formulation of budesonide/formoterol that is not available in the USA [2] and has never received US Food and Drug Administration/European Medicines Agency approval for use in acute asthma.

The change in recommendations by GINA leave few, if any, alternatives to this specific drug formulation and device, neither does it take account age groups that may not be able to use these devices, such as children, the aged or cognitively impaired. Currently there is only one European company that manufactures and markets this specific formulation/device combination. It should be of considerable concern that out of the 18 authors of this recently published manuscript, 12 (including all leading authors) have reported financial ties with that company.

Before the EU embraces the suggested GINA guideline change, the rather extensive ramifications should be discussed and the changes confirmed by an independent body of experts in asthma management including pharmacologists, adult and paediatric pulmonologists, internists and family practitioners with no potential conflicts of interest.

Finally, particularly in the USA, where off-label therapies may not be covered, this could cause considerable hardship for patients whose insurance would not reimburse the extremely high cost of albuterol pressurised metered-dose inhaler and formoterol DPI units.

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