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Open Access Research article

Real-life effectiveness of budesonide/formoterol maintenance and reliever therapy in asthma patients across Asia: SMARTASIA study

Nanshan Zhong1*, Jiangtao Lin2, Parthiv Mehta3, Pintip Ngamjanyaporn4, Tzu-Chin Wu5 and Faisal Yunus6

Author Affiliations

1 Respiratory Research Institute, 1st Affiliated Hospital of Guangzhou Medical College, Guangzhou, China

2 China-Japan Friendship Hospital, Beijing, China

3 Mehta’s Hospital and Cardiopulmonary Care Centre, Gujarat, India

4 Allergy Immunology and Rheumatology Division, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand

5 Chung Shan Medical University Hospital, Taichung, Taiwan

6 Department of Pulmonology and Respiratory Medicine, Faculty of Medicine, University of Indonesia, Persahabatan Hospital, Persahabatan, Indonesia

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BMC Pulmonary Medicine 2013, 13:22  doi:10.1186/1471-2466-13-22

Published: 4 April 2013

Abstract

Background

The use of budesonide/formoterol in a single inhaler for both maintenance and reliever therapy is a recommended option for treatment of persistent asthma not responding well to inhaled corticosteroid (ICS) alone.

Methods

This was a multi-centre open-label study on patients whose asthma condition remained inadequately controlled by various asthma treatments other than budesonide/formoterol. After a 2-week run-in period, eligible patients underwent a 12-week treatment period with budesonide/formoterol (Symbicort SMART®, 160/4.5 μg) twice daily plus as needed. Patient’s asthma control and quality of life were assessed using the 5-item Asthma Control Questionnaire (ACQ-5) and the standardized Asthma Quality of Life Questionnaire (AQLQ-S), respectively.

Results

A total of 862 eligible asthma patients who have had asthma for a mean duration of 10.73 ± 12.03 years entered a 12-week treatment with budesonide/formoterol maintenance and reliever therapy. During treatment, ACQ-5 score improved significantly by 0.58 ± 0.93 (95% CI, 0.51 to 0.64, P < 0.0001) from the baseline level of 1.62 ± 1.00. AQLQ(S) score improved by 0.70 ± 0.89 (95% CI, 0.64 to 0.76, P < 0.0001) from baseline. Asthma symptom score was also reduced significantly (P < 0.0001); between run-in and treatment periods, night- and day-time symptom scores were reduced by 0.32 ± 0.54 (95% CI, 0.28 to 0.35) and 0.30 ± 0.52 (95% CI, 0.27 to 0.34), respectively. The percentage of nights with awakenings due to asthma symptoms was reduced by 11.09 ± 26.13% (95% CI, 9.34 to 12.85%), while the percentage of asthma-control and symptom-free days increased by 20.90 ± 34.40% (95% CI, 18.59 to 23.21%) and 23.89 ± 34.62% (95% CI, 21.56 to 26.21%), respectively (P < 0.0001). Together with the improvement in asthma control, the number of night- and day-time inhalations of as-needed reliever medication decreased by 0.30 ± 0.82 (95% CI, 0.24 to 0.35) inhalations and 0.30 ± 0.97 (95% CI, 0.23 to 0.36) inhalations, respectively (P < 0.0001). No unexpected adverse events were reported.

Conclusion

During treatment of inadequately controlled asthmatic patients with budesonide/formoterol maintenance and reliever therapy, significant improvement in patients’ asthma control and reductions in asthma symptoms and as-needed medication use was observed. Patients’ quality of life was improved and the treatment was well tolerated.

Trial registration

ClinicalTrial.gov: (NCT00939341)

Keywords:
Asthma management; Asthma control; Budesonide/formoterol; Symbicort maintenance and reliever therapy