Asthma diagnosis and treatmentAsthma control can be maintained when fluticasone propionate/salmeterol in a single inhaler is stepped down
Section snippets
Study design
After a 2-week run-in period, this multicenter study had 2 treatment phases (Fig 1). Patients whose asthma was assessed as well controlled in each of the last 4 weeks of 12 weeks of open-label treatment with FSC (ADVAIR/SERETIDE/VIANI; GlaxoSmithKline, Greenford, United Kingdom) 250/50 μg twice daily were randomized into a 12-week, double-blind, parallel-group phase (step-down phase) comparing FSC 100/50 μg twice daily (inhaled corticosteroid reduced) with FP 250 μg twice daily (long-acting β2
Patient characteristics
A total of 855 patients were screened, 641 patients were included in the open-label phase, and 484 patients (246 treated with FSC and 238 treated with FP) were included in the ITT population for the double-blind step-down phase (Fig 2). Two hundred eight patients treated with FSC and 188 treated with FP were included in PP analyses.
Baseline characteristics at study entry and during run-in were similar for all patients entering the open-label phase and for randomized patients (Table I). The mean
Discussion
Current international asthma guidelines1 recommend that once asthma control has been achieved and maintained for 3 to 6 months, treatment should be reviewed and dose reduction of controller medication should be attempted, with careful monitoring to ensure that control is not lost. This advice is largely based on clinical experience, and few studies have examined the options and most favorable conditions for stepping down treatment. Questions that need to be addressed include whether step-down
References (16)
- et al.
Clinical equivalence of salmeterol/fluticasone propionate in combination (50/100mcg twice daily) when administered via a chlorofluorocarbon-free metered dose inhaler or dry powder inhaler to patients with mild to moderate asthma
Respir Med
(2001) - et al.
Development of the asthma control test: a survey for assessing asthma control
J Allergy Clin Immunol
(2004) - et al.
Worldwide severity and control of asthma in children and adults: the global Asthma Insights and Reality surveys
J Allergy Clin Immunol
(2004) Global Strategy for Asthma Management and Prevention. NHLBI/WHO workshop report
(2002)- et al.
Combination therapy with inhaled long-acting β2-agonists and inhaled corticosteroids: a paradigm shift in asthma management
Pharmacotherapy
(2002) - et al.
Is overall asthma control being achieved? a hypothesis-generating study
Eur Respir J
(2001) - et al.
Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma controL study
Am J Respir Crit Care Med
(2004) - et al.
Optimal asthma control, starting with high doses of inhaled budesonide
Eur Respir J
(2000)
Cited by (97)
GEMA 5.3. Spanish Guideline on the Management of Asthma
2023, Open Respiratory ArchivesReferral Criteria for Asthma: An Updated Consensus
2021, Open Respiratory ArchivesSerious Asthma Outcomes and Asthma Exacerbations with Maintenance on Inhaled Corticosteroid (Mometasone Furoate)/Long-Acting Beta Agonist (Formoterol) Combination Compared to Step Down to Mometasone Monotherapy
2020, Journal of Allergy and Clinical Immunology: In PracticeCitation Excerpt :Current asthma treatment guidelines suggest that patients on ICS/LABA combination therapy whose asthma has been controlled for at least 3 months can have their asthma therapy reduced either to a lower dose of ICS or discontinued from LABA.8 Potential loss of asthma control resulting in asthma exacerbation and the need for additional medication and hospitalization is a concern with either step-down approach, and has been the subject of many investigations.10,12-21 Previous randomized controlled studies examining the safety and efficacy of LABA step-down in patients with asthma on ICS/LABA combination therapy have generally been performed in relatively small patient populations and have not used guideline-based composite criteria for the detection of SAOs and asthma exacerbation.10,12-21
The Asthma Controller Step-down Yardstick
2019, Annals of Allergy, Asthma and ImmunologyInhaled corticosteroids and asthma control in adult-onset asthma: 12-year follow-up study
2018, Respiratory Medicine
Supported by GlaxoSmithKline R & D Limited.
Disclosure of potential conflict of interest: L. Jaques and M. Duggan are employed with and own stock in GlaxoSmithKline. E. D. Bateman has consultant arrangements with Boehringer Ingelheim, Pfizer, Aventis, Hoffmann le Roche, and GlaxoSmithKline; is on the speakers' bureau for AstraZeneca, Altana, Boehringer Ingelheim, GlaxoSmithKline, and Merck; and is on the advisory board for AstraZeneca, Altana, Boehringer Ingelheim, GlaxoSmithKline, and Hoffmann le Roche. C. Goldfrad is employed by GlaxoSmithKline. T. Atienza is on the speakers' bureau of GlaxoSmithKline Philippines Inc. T. Mihaescu has consultant arrangements with GlaxoSmithKline, AstraZeneca, and Merck Sharp Dohme and has received research support from GlaxoSmithKline.