SESSION TITLE: COPD
SESSION TYPE: Original Investigation Poster Discussion
PRESENTED ON: Monday, October 24, 2016 at 12:00 PM - 01:30 PM
PURPOSE: To evaluate treatment differences between nebulized ARF and placebo (PBO) with/without concomitant TIO on the risk of COPD-related hospitalizations.
METHODS: Data used in this analysis came from a multicenter, randomized, double-blind, simple safety, 52-week trial of nebulized ARF or PBO. Use of TIO was permitted. Inclusion criteria were COPD diagnosis with a forced expiratory volume/second (FEV1) ≤50% of predicted, FEV1/forced vital capacity ratio ≤70%, age ≥40 years, smoking history ≥15 pack years, and breathlessness severity grade ≥2. Key study outcomes included COPD exacerbation-related hospitalizations, and health-related quality of life assessed by St. George’s Respiratory Questionnaire (SGRQ). Poisson regression was used to estimate treatment differences in annualized COPD exacerbation-related hospitalization rates while patients were on treatment, adjusting for baseline smoking status, COPD severity, age, and exacerbation category (0, 1, or ≥2 exacerbations in the past year). Treatment differences in hospitalizations were also assessed in SGRQ responders (improvement in SGRQ total score by 4 points from baseline to month 12).