COPD
-
Multicenter Study
Gender differences of airway dimensions in anatomically matched sites on CT in smokers.
There are limited data on, and controversies regarding gender differences in the airway dimensions of smokers. Multi-detector CT (MDCT) images were analyzed to examine whether gender could explain differences in airway dimensions of anatomically matched airways in smokers. ⋯ Women smokers have higher WA%, but lower luminal area, internal diameter and airway thickness in anatomically matched airways as measured by CT scan than do male smokers. This difference may explain, in part, gender differences in the prevalence of COPD and airflow limitation.
-
Randomized Controlled Trial Multicenter Study
Cardiovascular safety of QVA149, a combination of Indacaterol and NVA237, in COPD patients.
This study assessed the cardiovascular safety of QVA149, an inhaled, once daily, bronchodilator combination containing two 24-hour bronchodilators, the long-acting β(2)-agonist indacaterol and the long-acting muscarinic antagonist glycopyrronium (NVA237). In this randomised, double-blind, placebo-controlled, parallel-group study, 257 patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) were randomised to receive QVA149 (indacaterol/NVA237) 600/100 microg, 300/100 microg or 150/100 microg, indacaterol 300 μg or placebo, once daily for 14 days. The primary endpoint was change from baseline in 24-h mean heart rate versus placebo on Day 14. 255 patients were included in the safety analysis (mean age 63.8 years, 76.5% male, post-bronchodilator forced expiratory volume in one second [FEV(1)] 53.2% predicted, FEV(1)/FVC [forced vital capacity] 50.0%, mean 24-h heart rate 79.6 bpm). ⋯ The confidence intervals of these treatment differences (contrasts) were within the pre-specified equivalence limit (-5 to 5 bpm). No clinically relevant differences in QTc interval (Fridericia's) were observed between groups on Days 1, 7 and 14. Once-daily QVA149 was well tolerated in COPD patients with a cardiovascular safety profile and overall adverse event rates similar to placebo.
-
Randomized Controlled Trial Multicenter Study Comparative Study
Onset of effect of aclidinium, a novel, long-acting muscarinic antagonist, in patients with COPD.
ABSTRACT Aclidinium bromide is a novel, long-acting, inhaled muscarinic antagonist in development for the treatment of chronic obstructive pulmonary disease (COPD). The aim of this study was to assess the rate of onset of bronchodilation with aclidinium compared with placebo and tiotropium. This was a double-blind, double-dummy, multicenter, crossover study in COPD patients with a post-bronchodilator forced expiratory volume in 1 second (FEV(1)) ≥30% and <60% predicted. ⋯ At 30 minutes, the relative increase from baseline in FEV(1) was significantly higher for aclidinium and tiotropium versus placebo (12% and 11% versus 3%; p < 0.0001). Aclidinium and tiotropium also significantly increased FEV(1) (p < 0.01) and improved the perception of dyspnea compared with placebo at all measured time points from 10 minutes to 3 hours post-dose. In conclusion, aclidinium provided effective bronchodilation, similar to that seen with tiotropium, with significant improvements compared with placebo observed from 10 minutes post-dose.
-
Multicenter Study Comparative Study
Significant bronchodilator responsiveness and "reversibility" in a population sample.
Chronic Obstructive Pulmonary Disease (COPD) is defined by being "not fully reversible", most guidelines recommend measurement of lung function after the administration of a bronchodilator. The objective of this study was to compare bronchodilator responsiveness (significant improvement in the FEV(1) or FVC) to full-, partial- or "inverse'" reversibility in obstruction status in a population-based sample in Southeastern Kentucky. The study population was selected using random digit dialing of an adult population in Southeastern Kentucky as part of the Burden of Lung disease (BOLD) project. ⋯ Among those with full-reversibility, only 9/32 (28.1%) had bronchodilator responsiveness, whereas among subjects with "inverse"-reversibility, 10/19 (52.6%) had bronchodilator responsiveness. Among all subjects with bronchodilator responsiveness, only 19/65 (29.2%) changed categories. Our findings suggest that significant bronchodilator responsiveness is not the same as "reversibility" of "obstruction", even though these terms are often used interchangeably.
-
Multicenter Study Comparative Study
Hospitalizations for acute exacerbations of chronic obstructive pulmonary disease: how you count matters.
ICD-9-CM diagnosis codes are increasingly used to estimate the burden of disease, as well as to evaluate the quality of care and outcomes of various conditions. Acute exacerbations of COPD (AE-COPD) are common and associated with substantial health and financial burden in the U. S. ⋯ Observed trends in the number of hospitalizations over the 7-year period varied depending on which algorithm was used. In conclusion, the estimated health burden and trends in hospitalizations for AE-COPD in the United States differ, depending on which ICD-9-CM algorithm is used. To improve our understanding of the burden of AE-COPD and to ensure that quality of care initiatives are not misdirected, a validated approach to identifying patients hospitalized for AE-COPD is needed.