Clinical Drug Investigation

, Volume 30, Issue 9, pp 565–579

Treatment Comparison of Budesonide/Formoterol with Salmeterol/Fluticasone Propionate in Adults Aged ≥ 16 Years with Asthma

Post Hoc Analysis of a Randomized, Double-Blind Study
Original Research Article

Abstract

Background

Three fixed maintenance-dose inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) combinations for the treatment of asthma are currently available: salmeterol/fluticasone propionate (Seretide™/Advair™/Adoair™) budesonide/formoterol (Symbicort®) and beclometasone/formoterol (Foster™). All of these combinations have proven efficacy in terms of controlling symptoms, improving lung function and reducing the rate of exacerbations compared with ICSs and LABAs administered separately. Budesonide/formoterol is also approved for use as maintenance and reliever therapy in a number of countries (Symbicort SMART®). Many of the studies supporting the use of budesonide/formoterol combination therapies have included populations of adolescents and adults aged >11 years.

Objective

This post hoc analysis compared the efficacy of ICS/LABA fixed maintenance-dose treatment with budesonide/formoterol and salmeterol/fluticasone propionate versus budesonide/formoterol maintenance and reliever therapy in patients with persistent asthma aged ≥16 years.

Methods

Following 2-weeks’ run-in, 2866 adults aged ≥16 years were randomized to: fixed maintenance-dose budesonide/formoterol 640 µg/18 µg per day, salmeterol/fluticasone propionate 100 µg/500 µg per day plus terbutaline as needed, or budesonide/formoterol 320 µg/9 µg per day plus additional inhalations as needed (budesonide/formoterol maintenance and reliever therapy). Outcome measures included time to first severe asthma exacerbation (primary outcome) and number of severe asthma exacerbations.

Results

Budesonide/formoterol maintenance and reliever therapy prolonged time to first severe exacerbation versus budesonide/formoterol and salmeterol/fluticasone propionate fixed maintenance dose (p = 0.037 and p = 0.0089, respectively). Compared with salmeterol/fluticasone propionate fixed maintenance-dose treatment, fixed maintenance-dose budesonide/formoterol reduced the risk of hospitalizations/emergency-room visits by 28% (relative rate [RR] 0.72; 95% CI 0.53, 0.98; p = 0.034) and budesonide/formoterol maintenance and reliever therapy by 37% (RR 0.63; 95% CI 0.46, 0.87; p = 0.0043). All treatments provided similar improvements in lung function, asthma control days and asthma-related quality of life.

Conclusion

Budesonide/formoterol fixed maintenance dose or maintenance and reliever therapy provides similar improvements in current asthma control and reduces the future risk of hospitalizations/emergency-room treatments versus salmeterol/fluticasone propionate fixed maintenance-dose treatment, providing additional clinical benefit to asthma patients aged ≥16 years.

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Copyright information

© Adis Data Information BV 2010

Authors and Affiliations

  1. 1.Division of Internal Medicine, Asthma and AllergyBarlicki University Hospital, Medical University of LodzLodzPoland

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