title: INSTEAD: a randomised switch trial of indacaterol versus salmeterol/fluticasone in moderate COPD.
abstract: The Indacaterol: Switching Non-exacerbating Patients with Moderate COPD From Salmeterol/Fluticasone to Indacaterol (INSTEAD) study investigated the effect of switching patients at low risk of chronic obstructive pulmonary disease (COPD) exacerbations from salmeterol/fluticasone (SFC; inhaled corticosteroid (ICS) regimen) to indacaterol monotherapy (non-ICS regimen). This 26-week, double-blind, double-dummy, parallel-group, phase IV study, randomised 581 patients with moderate COPD to indacaterol 150 μg once daily or SFC 50/500 μg twice daily. Patients had been receiving SFC 50/500 μg for ≥3 months, with no COPD exacerbations for more than a year before the study (patients for whom ICS is not recommended). The primary objective was to demonstrate non-inferiority of indacaterol to SFC, measured by trough forced expiratory volume in 1 second (FEV₁) 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 exacerbation rates over 26 weeks. Safety profiles of both treatments were as expected. This study demonstrated that patients with moderate COPD and no exacerbations in the previous year can be switched from SFC to indacaterol 150 μg with no efficacy loss.
authors.affiliation: Pulmonary Unit, University of Verona, Verona, Italy andrea.rossi_03@univr.it.
authors.forename: Andrea
authors.initials: A
authors.lastname: Rossi
authors.affiliation: University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
authors.forename: Thys
authors.initials: T
authors.lastname: van der Molen
authors.affiliation: Fundación CIDEA and Hospital Maria Ferrer, Buenos Aires, Argentina.
authors.forename: Ricardo
authors.initials: R
authors.lastname: del Olmo
authors.affiliation: University of Ferrara, Ferrara, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Papi
authors.affiliation: Fundacion Enfisema, Buenos Aires, Argentina.
authors.forename: Luis
authors.initials: L
authors.lastname: Wehbe
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
authors.forename: Matthew
authors.initials: M
authors.lastname: Quinn
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
authors.forename: Chengxing
authors.initials: C
authors.lastname: Lu
authors.affiliation: Novartis Horsham Research Centre, Horsham, UK.
authors.forename: David
authors.initials: D
authors.lastname: Young
authors.affiliation: Novartis Horsham Research Centre, Horsham, UK.
authors.forename: Ray
authors.initials: R
authors.lastname: Cameron
authors.affiliation: Novartis Farma, Origgio, Italy.
authors.forename: Enrica
authors.initials: E
authors.lastname: Bucchioni
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
authors.forename: Pablo
authors.initials: P
authors.lastname: Altman
mesh_terms: D000280:Administration, Inhalation; D000368:Aged; D000420:Albuterol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000730:Androstadienes / Q000627:therapeutic use*; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D018450:Disease Progression; D004311:Double-Blind Method; D004338:Drug Combinations; D057915:Drug Substitution; D005260:Female; D000068297:Fluticasone-Salmeterol Drug Combination; D005541:Forced Expiratory Volume; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D007189:Indans / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D015363:Quinolones / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014797:Vital Capacity
chemical_list: D000730:Androstadienes; D001993:Bronchodilator Agents; D004338:Drug Combinations; D000068297:Fluticasone-Salmeterol Drug Combination; D005938:Glucocorticoids; D007189:Indans; D015363:Quinolones; C510790:indacaterol; D000420:Albuterol