Integrating indacaterol dose selection in a clinical study in COPD using an adaptive seamless design

PJ Barnes, SJ Pocock, H Magnussen, A Iqbal… - Pulmonary …, 2010 - Elsevier
BACKGROUND: The drug development process can be streamlined by combining the
traditionally separate stages of dose-finding (Phase IIb) and confirmation of efficacy and
safety (Phase III) using an adaptive seamless design. This approach was used in a clinical
study of indacaterol, a novel once-daily (od) inhaled long-acting β2-adrenoreceptor agonist
bronchodilator for the treatment of COPD (chronic obstructive pulmonary disease).
METHODS: The study comprised a dose-finding stage with dose selection after 14 days of …

Integrating Indacaterol Dose Selection in a Clinical Study in COPD Using an Adaptive Seamless Design.

PJ Barnes, SJ Pocock, H Magnussen… - C48. COPD …, 2009 - atsjournals.org
INTRODUCTION Indacaterol (IND) is a novel once− daily (qd) inhaled β2− agonist in clinical
development for COPD. METHODS In an adaptive seamless design phase II/III study, data
from Stage 1 (≥ 2 weeks) were evaluated by independent committee using pre− set criteria
to select two IND doses to continue into Stage 2 (26 weeks). Selection was based on IND
efficacy (24− h trough FEV1 after 14 days (assessed on morning of Day 15) and FEV1 AUC
1− 4 h at Day 14 vs formoterol [FOR] and tiotropium [TIO]) and safety (adverse events, ECG …
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