INSTEAD: a randomised switch trial of indacaterol versus salmeterol/fluticasone in moderate COPD

The Indacaterol: Switching Non- exacerbatingPatients with Moderate COPD From Salmeterol/ Fluticasoneto Indacaterol(INSTEAD) study investigated the effect of switching patients at low risk of chronic obstructive pulmonary disease ( COPD) exacerbationsfrom salmeterol/ fluticasone(SFC; inhaled corticosteroid (ICS) regimen) to indacaterolmonotherapy (non-ICS regimen). This 26-week, double-blind, double-dummy, parallel-group, phase IV study, randomised 581 patients with moderate COPD to indacaterol150 μg once daily or SFC 50/500 μg twice daily. Patients had been receiving SFC 50/500 μg for ≥3 months, with no COPD exacerbationsfor more than a year before the study (patients for whom ICS is not recommended). The primary objective was to demonstrate non-inferiority of indacaterolto SFC, measured by trough forced expiratory volume in 1 second (FEV 1 ) after 12 weeks (non-inferiority margin of 0.06 L). The primary objective was met, with a mean treatment difference of 9 mL (95% CI -45–26 mL). There were no significant differences between treatments in terms of breathlessness (transition dyspnoea index) or health status (Saint George’s Respiratory Questionnaire) at weeks 12 or 26, or rescue medication use or COPD exacerbationrates over 26 weeks. Safety profiles of both treatments were as expected. This study demonstrated that patients with moderate COPD and no exacerbationsin the previous year can be switched from SFC to indacaterol150 μg with no efficacy loss.