Real-Life Efficacy of Indacaterol and Other LABAs in COPD Patients in Israel

Abstract

PURPOSE: Indacaterol (IND) is a once daily long acting beta 2 agonist (LABA). This study evaluated how IND can be introduced into real life treatment regimens for COPD in Israel. A 12 week multicenter, randomized, open label study in patients (Pts) with moderate to severe COPD, aged 40 years and older, whose current treatment regimen included a LABA. Pts were randomized to either change current LABA to IND, or to remain on their previous treatment. In both arms pts who were treated with inhaled corticosteroids (ICS) were allowed to continue ICS. The primary objective was change in health-related quality of life (HRQoL) measured by COPD Clinical Questionnaire (CCQ) score change from baseline to week 121. 90 pts were randomized (60 to IND and 30 to control), mean age 65.2±9.9 yrs. At 12 weeks the IND arm demonstrated an improvement in HRQoL reflected by a decrease from baseline in mean±SEM CCQ score of 0.2±0.8.HRQoL deteriorated from baseline in the control group , with an increase in mean CCQ of 0.2±0.9.The 0.4 delta between the groups in CCQ score showed borderline statistical significance (Ptrend= 0.0595).This difference meets the CCQ score minimally important difference (0.4). Use of IND was not associated with any significant safety concerns. Administration of once daily IND 150 mcg to COPD pts previously treated with other LABAs led to an improvement in pts' QoL. The borderline statistical significance is probably due to the small number (90) of pts included in this study. This study was designed to evaluate how IND can be introduced into real life treatment regimens for COPD, by effectively and safely replacing other LABA.