RT Journal Article
SR Electronic
T1 Asthma control and lung function after step down from high dose ICS/LABA combination therapy
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP p3967
VO 38
IS Suppl 55
A1 Pierluigi Paggiaro
A1 Gabriele Nicolini
A1 Nunzio Crimi
A1 Leonardo Maria Fabbri
A1 Dario Olivieri
A1 Andrea Rossi
A1 Alberto Papi
YR 2011
UL http://erj.ersjournals.com/content/38/Suppl_55/p3967.abstract
AB Rationale: Guidelines recommend asthma treatment to be adjusted to the lowest dose maintaining control.Objectives: To evaluate whether lung function and asthma control can be maintained in patients treated with high dose ICS/LABA combination after step-down.Methods: Prospective, multinational, randomized, open label, parallel group controlled trial. Patients treated with high dose (1000/100 μg daily) fluticasone/salmeterol (FP/S) either DPI or pMDI entered a 2-month run-in with FP/S Diskus 1000/100 μg daily. Controlled patients (GINA) were treated with either FP/S Diskus 500/100 μg daily or extrafine beclomethasone/formoterol (BDP/F) pMDI 400/24 μg daily for 6 months. Morning PEF was the primary outcome. Secondary outcomes included asthma control.Results: 378 patients were evaluated for ITT; previous treatment was DPI in 87% of patients. Equivalence was shown in morning PEF at the end of treatment (difference between means 2.49 L/min; 95% CI -13.43 to 18.42).Morning PEF remained above 95% predicted throughout the study, though absolute values decreased (414.4 to 397.1 L/min for BDP/F; 429.7 to 394.6 L/min for FP/S; p=0.0001). Asthma control was maintained in the majority of patients with no worsening in FEV1 measured at clinics, symptoms score, use of rescue medication and no differences in any parameter including exacerbations.View this table:Conclusions: Patients controlled with high dose ICS/LABA DPI can be stepped-down to medium dose either DPI or extrafine pMDI mantaining asthma control.