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Randomized Controlled Trial
. 2012 Mar;21(1):50-6.
doi: 10.4104/pcrj.2011.00090.

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

Roland A Riemersma  1 , Dirkje Postma, Thys van der Molen
Affiliations
Randomized Controlled Trial

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

Roland A Riemersma et al. Prim Care Respir J. 2012 Mar.

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 80/4.5 μg 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 326 μg 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 (798 μg 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.

Trial registration: ClinicalTrials.gov NCT00235911.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1. Study flow chart, V = visit, T = telephone contact
Figure 2
Figure 2. Enrolment of patients and completion of the study
Figure 3
Figure 3. Comparison of clinical characteristics of the current study with other SMART studies at baseline
Figure 4
Figure 4. ICS dose in μg BDP equivalents at baseline and after 1, 3, 6 and 12 months of treatment
See this image and copyright information in PMC

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