Budesonide/Formoterol Anti-Inflammatory Reliever and Maintenance or Fluticasone Propionate/Salmeterol Plus As-Needed, Short-Acting β₂ Agonist: Real-World Effectiveness in pAtients without Optimally Controlled asThma (REACT) Study

Abstract

Introduction

In the prospective, observational, 16-week REACT study conducted between October 21, 2008 and May 12, 2011, we compared the real-world effectiveness of anti-inflammatory reliever and maintenance therapy with budesonide/formoterol (Symbicort^® Turbuhaler) and maintenance therapy with fixed-dose fluticasone/salmeterol (Seretide^®) plus as-needed, short-acting β₂ agonists (SABAs) in Taiwanese patients with inadequate asthma control.

Methods

Asthma control was assessed using the five-item Asthma Control Questionnaire (ACQ-5) and standardized pulmonary function testing. Assessments were performed at baseline and at weeks 4–5 and 12–16. Overall, we enrolled 842 patients at 11 clinics, 723 of whom were included in analyses (budesonide/formoterol, 563.3±1.3 μg/d, n=551; fluticasone/salmeterol, 1013.8±1.4 μg/d, n=172).

Results

At baseline, 72.5% and 27.5% of all patients had “partly” and “uncontrolled” asthma, respectively. Mean±SD ACQ-5 scores were 1.54±1.06 and 1.46±1.28 in the budesonide/formoterol and fluticasone/salmeterol groups, respectively. ACQ-5 scores significantly improved from baseline (ie, decreased) in both groups at weeks 4 and 16. ACQ-5 difference scores were significantly lower in the budesonide/formoterol group (−0.91±1.11) than the fluticasone/salmeterol group (−0.69±1.27) at the end of the study (p=0.027). Peak expiratory flow rate significantly improved from baseline in the budesonide/formoterol but not the fluticasone/salmeterol group at the end of the study. Severe exacerbation rates and medical resource utilization were comparable between the budesonide/formoterol and fluticasone/salmeterol groups.

Conclusion

Collectively, results indicate the real-world effectiveness of budesonide/formoterol anti-inflammatory reliever and maintenance therapy is better than fixed-dose fluticasone/salmeterol plus as-needed SABA.

Trial Registration

ClinicalTrials.gov registration number: NCT00784953.

Keywords:

• budesonide/formoterol
• fluticasone propionate/salmeterol
• anti-inflammatory reliever and maintenance
• real-world

View correction statement:

Budesonide/Formoterol Anti-Inflammatory Reliever and Maintenance or Fluticasone Propionate/Salmeterol Plus as-Needed, Short-Acting β2 Agonist: Real-World Effectiveness in patients Without Optimally Controlled asthma (REACT) Study [Corrigendum]

Acknowledgments

Medical writing and/or editorial assistance in the form of assembling tables, collating author comments, copyediting, fact checking, and referencing based on authors’ detailed directions, was provided by Vidula Bhole, MD, MHSc, Shruti Baijal Ph.D. and Maribeth Bogush, MCI, PhD of Cactus Communications. This assistance was funded by AstraZeneca Taiwan. The authors retained full control of the manuscript content.

Clinical Trial Registration

This study was registered at www.ClinicalTrials.gov with clinical trial identifier no. NCT00784953.

Disclosure

The REACT study was supported by AstraZeneca Taiwan. The authors declare that there are no additional conflicts of interest.