Article

Budesonide/formoterol maintenance and reliever therapy in primary care asthma management: effects on bronchial hyperresponsiveness and asthma control

  • Primary Care Respiratory Journal (2011) 21, 5056
  • doi:10.4104/pcrj.2011.00090
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Abstract

Background:

The management of asthma has changed since the introduction of budesonide/formoterol (Symbicort®) as both maintenance and reliever therapy (SMART). SMART and its effects on bronchial hyperresponsiveness (BHR) have not been studied in primary care.

Aims:

To compare the effects of SMART and guideline-driven usual care (UC) on BHR and clinical asthma severity in primary care practice.

Methods:

Patients with mild-to-moderate stable asthma were randomised to receive SMART treatment (n=54) (budesonide/formoterol 80/4.5μg Turbuhaler®, two puffs once daily and extra inhalations as needed) or UC treatment (n=48) for 12 months. Diary data, Asthma Control Questionnaire scores, forced expiratory volume in 1 second (FEV1), and peak expiratory flow (PEF) measurements were collected during run-in and after 1, 3, 6, and 12 months of treatment. BHR, measured as the dose of histamine provoking a fall in FEV1 of 20% (PD20-histamine), was determined at randomisation and after 12 months.

Results:

One hundred and two patients with asthma participated in the study. The change in PD20-histamine during the study was not significantly different between the SMART and UC groups (p=0.26). The mean inhaled corticosteroid (ICS) dose was 326μg beclomethasone dipropionate (BDP) equivalents/day (95% CI 254 to 399) with SMART, which was significantly lower (p<0.0001) than the mean ICS dose with UC treatment (798μg BDP equivalents/day (95% CI 721 to 875). Morning and evening PEF values increased significantly with SMART treatment compared with UC; FEV1, symptoms and asthma control did not differ.

Conclusions:

Despite a 59% lower dose of ICS, BHR and other clinical outcomes remained stable during SMART treatment while PEF values improved.

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Acknowledgements

Handling editor Mike Thomas

Statistical review Gopal Netuveli

Funding This study was supported by an unrestricted educational grant by AstraZeneca BV, The Netherlands. The sponsors were involved in the study design and interpretation of the data, always in conjunction with the study investigators.

Trial registration This trial is registered at: http://www.clinicaltrials.gov, identifier: NCT00235911.

Author information

Affiliations

  1. Department of General Practice, University Medical Center Groningen, Groningen, The Netherlands

    • Roland A Riemersma
    • , Dirkje Postma
    •  & Thys van der Molen
  2. Department of Pulmonary Medicine and Tuberculosis, University Medical Center Groningen, Groningen, The Netherlands

    • Roland A Riemersma
    •  & Dirkje Postma

Authors

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Contributions

The authors wrote the manuscript. Employees of the sponsor performed data monitoring. Data analysis was performed by employees of the sponsor and the authors. The corresponding author had access to the full clinical trial database and all authors had free access to the clinical study report and the results of the statistical analyses. Employees of the sponsor reviewed drafts of the manuscript and made editing suggestions. All authors made the final decisions on all aspects of the manuscript.

Competing interests

RAR has received a research grant from AstraZeneca (AZ); and speaking fees, consulting fees, and reimbursement for attending conferences from AZ, GlaxoSmithKline (GSK), Boehringer, and MSD. DP has received a research grant from AZ; speaking fees, consulting fees, and reimbursement for attending conferences from AZ, GSK, MSD, Novartis, and Nycomed; funding for research from AZ, GSK, and Nycomed; travel to the ERS or ATS partially funded by AZ, GSK, Chiesi, and Nycomed; and she has been consultant to AZ, Boehringer Ingelheim, Chiesi, GSK, Nycomed, and TEVA. TvdM has received research grants from AZ, Nicomed, and MSD; speaking fees, consulting fees, and reimbursement for attending conferences from AZ and GSK; and has been consultant to AZ, MSD, Nicomed, and Novartis.

Corresponding author

Correspondence to Roland A Riemersma.

Appendices

Appendix 1: Enrolment, exclusion and randomisation criteria