COPD
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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.
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Randomized Controlled Trial
A randomised crossover trial comparing volume assured and pressure preset noninvasive ventilation in stable hypercapnic COPD.
Recent randomised controlled trials suggest non-invasive ventilation may offer benefit in the long-term management of ventilatory failure in stable COPD. The best mode of ventilation is unknown and newer volume assured modes may offer advantages by optimising ventilation overnight when treatment is delivered. This study compares volume assured with pressure preset non-invasive ventilation. ⋯ No significant differences were seen in primary or secondary outcomes following 8 weeks of treatment when comparing volume assured and pressure preset ventilation. Primary outcomes assessed: mean (standard deviation) PaO(2) 7.8 (1.2) vs 8.1(1) kPa, PaCO(2) 6.7 (1.1) vs 6.3 (1.2) kPa and mean nocturnal oxygenation 90 (4) vs 91 (3)% volume assured versus pressure preset, respectively. Volume assured and pressure preset non-invasive ventilation appear equally effective in the long-term management of ventilatory failure associated with stable COPD.
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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.
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Randomized Controlled Trial Multicenter Study
The safety and efficacy of arformoterol and formoterol in COPD.
This study evaluated the safety and efficacy of arformoterol and formoterol over 6-months in subjects with COPD. In a multi-center, 6-month randomized, double-blind, double-dummy trial, subjects with COPD (mean FEV(1) 1.21 L, approximately 41.0% predicted) were randomized to receive either nebulized arformoterol (15 microg BID [n = 149][ARF 15], 25 microg BID [n = 147][ARF 25]), or racemic formoterol (12 microg BID [n = 147][FORM]) delivered by DPI. The proportion of subjects with any post-treatment adverse event for ARF 15, ARF 25 microg, and FORM was 67.8%, 76.2% and 66.7%, respectively, and those with at least one COPD exacerbation was 32.2%, 30.6%, and 22.4%, respectively. ⋯ Dyspnea, (mean Transition Dypsnea Index (TDI) focal score) improved in all treatment arms (ARF 15: 1.4, ARF 25: 1.5, and FORM: 1.4) at 6 months, as did rescue short-acting beta(2)-agonists use (mean range: -1.1 to -1.3 actuations/day) and ipratropium bromide (mean range: -0.3 to -0.8 actuations/day). Health status, measured by St George's Respiratory Questionnaire, improved from baseline at 6-months in all treatment groups (mean change: -3.7 to -6.8). In this 6-month study, arformoterol and formoterol were well-tolerated, and their use was associated with improvement in pulmonary function and health status in subjects with COPD with no apparent development of tolerance.
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Randomized Controlled Trial Comparative Study
A double-blind crossover study comparing the safety and efficacy of three weeks of Flu/Sal 250/50 bid plus albuterol 180 ug prn q4 hours to Flu/Sal 250/50 bid plus albuterol/Ipratropium bromide 2 puffs prn q4 hours in patients with chronic obstructive pulmonary disease.
The Federal Drug Administration (FDA) approved the use of Fluticasone 250 microg/Salmeterol 50 microg 1 puff bid for maintenance therapy in patients with COPD associated with chronic bronchitis. Short-acting beta agonists (SABA) have been the recommended rescue medication; however, previous studies have shown that combination short-acting Albuterol (alb) /Ipratropium bromide (IB) has superior bronchodilator properties to albuterol alone in patients with COPD. The safety and efficacy of Albuterol compared to Albuterol/Ipratropium bromide as rescue medications for COPD patients on maintenance combination therapy of ICS/LABA has not been evaluated. ⋯ The mean baseline FEV(1) (range) was 1.12 L (0.56-1.67) or 40.6 (21-65)% predicted. There were no statistically significant differences between either rescue inhaler formulation with regard to measures neither of lung function or dyspnea nor in terms of safety parameters of cardiac monitoring, glucose and potassium levels and other adverse events. SABA and combination SABA/Ipratropium bromide are equally safe and efficacious as rescue inhalers for patients on combination Fluticasone 500 microg/Salmeterol 50 microg.