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- David Shitrit, Yehuda Schwarz, Gabriel Izbicki, Gershon Fink, Meir Raz, Zeev Vilayi-Weiler, Sari Lubin, Lital Daniel, and Tamar Rachmilewitz.
- Chest. 2014 Mar 1;145(3 Suppl):431B.
Session TitleCOPD Case Report PostersSESSION TYPE: Case Report PosterPRESENTED ON: Sunday, March 23, 2014 at 01:15 PM - 02:15 PMPURPOSE: 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.MethodsA 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.Results90 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.ConclusionsAdministration 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.Clinical ImplicationsThis study was designed to evaluate how IND can be introduced into real life treatment regimens for COPD, by effectively and safely replacing other LABA.DisclosureGabriel Izbicki: Consultant fee, speaker bureau, advisory committee, etc.: Advisor Honorarium David Shitrit: Consultant fee, speaker bureau, advisory committee, etc.: Advisor Honorarium Meir Raz: Consultant fee, speaker bureau, advisory committee, etc.: Advisor Honorarium Zeev Vilayi-Weiler: Consultant fee, speaker bureau, advisory committee, etc.: Advisor Honorarium Gershon Fink: Consultant fee, speaker bureau, advisory committee, etc.: Advisor Honorarium Yehuda Schwarz: Consultant fee, speaker bureau, advisory committee, etc.: Advisor Honorarium Sari Lubin: Employee: Salary Lital Daniel: Employee: Salary Tamar Rachmilewitz: Employee: Salary Mordechai Kramer: Consultant fee, speaker bureau, advisory committee, etc.: Advisor HonorariumNo Product/Research Disclosure Information.
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