Article Text

PDF

Maintenance and symptom relief with budesonide plus formoterol reduced severe asthma exacerbations
  1. Susan A Bruce, RN, MS, NP,
  2. Yvonne K Scherer, RN, EdD, CNS
  1. University at Buffalo
    Buffalo, New York, USA

Statistics from Altmetric.com

OpenUrlCrossRefPubMedWeb of Science

Q In patients with asthma, is budesonide (BUD) plus formoterol (FORM) (BUDFORM) for both maintenance and symptom relief more effective than fixed dosing using BUDFORM or a 4 fold higher dose of BUD, both with a short acting β2 agonist (SABA), for reducing the rate of severe asthma exacerbations?

METHODS

Embedded ImageDesign:

randomised controlled trial.

Embedded ImageAllocation:

concealed.

Embedded ImageBlinding:

blinded (patients and healthcare providers).

Embedded ImageFollow up period:

1 year

Embedded ImageSetting:

246 centres in 22 countries.

Embedded ImagePatients:

2760 outpatients (mean age 36 y, 55% women/girls; 12% children 4–11 y) with asthma who were using inhaled corticosteroids (ICSs).

Embedded ImageIntervention:

BUDFORM (BUD, 80 μg plus FORM, 4.5 μg) both for maintenance and as needed (BUDFORM for all, n = 925); BUDFORM for maintenance plus terbutaline, 0.4 mg as needed (BUDFORM plus SABA, n = 909); or BUD, 320 μg, plus terbutaline (BUD plus SABA, n = 926). All maintenance treatments were twice daily for patients 12–80 years of age and once daily for children 4–11 years of age.

Embedded ImageOutcomes:

time to first severe asthma exacerbation (deterioration in asthma resulting in hospital admission or emergency department treatment, oral steroid treatment, or morning peak expiratory flow ⩽70% of baseline on 2 consecutive days).

Embedded ImagePatient follow up:

99.7% of patients were included in the intention to treat analyses.

MAIN RESULTS

Time to first severe exacerbation was longer in the BUDFORM-for-all group than in the BUDFORM plus SABA group or BUD plus SABA group (p values <0.001). Fewer patients in the BUDFORM-for-all group than in the BUDFORM plus SABA group or BUD plus SABA group had ⩾1 severe asthma exacerbation (table).

Budesonide (BUD) plus formoterol (FORM) for both maintenance and symptom relief (BUDFORM for all) v fixed dosing using BUDFORM or a 4 fold higher dose of BUD, both with a short acting β2 agonist (SABA) in asthma*

CONCLUSION

In patients with asthma, budesonide plus formoterol (BUDFORM) for both maintenance and symptom relief was more effective than fixed dosing using BUDFORM or a 4 fold higher dose of budesonide, both with a short acting β2 agonist, for reducing severe asthma exacerbations.

A modified version of this abstract appears in Evidence-Based Medicine.

Commentary

Acute asthma exacerbations are a major cause of morbidity for patients of all ages but can be successfully managed with treatment plans that include long acting β agonists (LABAs) and ICSs. The trial by O’Bryne et al is one of the first to examine the effect of a combination of an LABA and an ICS inhaler for use on a maintenance and as needed basis in patients of all ages.

Study treatments were guided by patient age group: 4–11 and 12–80 years. The latter group, however, is not truly reflective of adults because it includes adolescents, young and middle aged adults, and the elderly. Each of these groups has different physiological pharmacokinetics such as rates of absorption and metabolism. Generalised dosing is contrary to the Global Initiative for Asthma1 recommendation of individualised dosing, especially at either end of the age spectrum. In addition, use of terbutaline as an SABA has declined in the US and the safety of its use in children <12 years of age is not established.2 Therefore, the interventions may not be broadly reflective of practice and might preclude wide application of results to all clinical settings.

However, the results have important implications for nurses and advanced practice nurses. Using an LABA (with properties for both maintenance and quick relief) plus an ICS addresses the anti-inflammatory and bronchodilator needs of patients with asthma in one medication. A patient’s ability to increase the dose of both can result in less use of systemic steroids, less frequent exacerbations, and less expensive medical interventions.

References

View Abstract

Footnotes

  • For correspondence: Dr P M O’Byrne, St Joseph’s Hospital, Hamilton, Ontario, Canada. obyrnepmcmaster.ca

  • Source of funding: AstraZeneca R&D, Lund, Sweden.

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.