TY - JOUR
T1 - A pilot study to assess the effects of combining fluticasone propionate/salmeterol and tiotropium on the airflow obstruction of patients with severe-to-very severe COPD
AU - Cazzola, Mario
AU - Andò, Filippo
AU - Santus, Pierachille
AU - Ruggeri, Paolo
AU - Di Marco, Fabiano
AU - Sanduzzi, Alessandro
AU - D'Amato, Maria
PY - 2007/10
Y1 - 2007/10
N2 - The aim of this pilot study was to explore the relative efficacy in terms of improvement in symptoms and lung function of combining fluticasone propionate/salmeterol combination (FSC) and tiotropium in patients with severe-to-very severe stable COPD. Ninety patients were randomized to receive 3 months of treatment in one of three treatment groups: (1) FSC 500/50 μg Diskus, 1 inhalation twice daily+placebo Handihaler 1 inhalation once-daily daily; (2) tiotropium 18 μg Handihaler, 1 inhalation once daily+placebo Diskus, 1 inhalation twice daily; (3) FSC 500/50 μg Diskus, 1 inhalation twice daily+tiotropium 18 μg Handihaler, 1 inhalation once-daily daily. Patients attended the clinic before and after 1 month, 2 months, and 3 months of treatment for evaluations of pulmonary function, and dyspnea, which was assessed using a visual analog scale (VAS). Also the supplemental salbutamol use was measured. Eighty-one patients completed the 3-month treatment period: 26 patients receiving FSC, 26 patients receiving tiotropium, and 29 patients receiving FSC+tiotropium. Patients were withdrawn for COPD exacerbation. Improvements in trough FEV1 with all treatments medications were observed by the first month when trough FEV1 had improved significantly above baseline by 74 mL (p <0.05) in the tiotropium group, by 117 mL (p <0.05) in the FSC group and by 115 mL (p <0.05) in FSC+tiotropium group. At the end of the study, trough FEV1 had improved significantly above baseline by141 mL (p <0.05) in the tiotropium group, by 140 mL (p <0.05) in the FSC group and by 186 mL (p <0.05) in FSC+tiotropium group. The difference between FSC and tiotropium appeared to decrease, that between FSC and FSC+tiotropium appeared to increase and that between tiotropium and FSC+tiotropium remained almost similar with study duration. Our results suggest that adding FSC and tiotropium may provide benefits in symptomatic patients with severe-to-very severe stable COPD.
AB - The aim of this pilot study was to explore the relative efficacy in terms of improvement in symptoms and lung function of combining fluticasone propionate/salmeterol combination (FSC) and tiotropium in patients with severe-to-very severe stable COPD. Ninety patients were randomized to receive 3 months of treatment in one of three treatment groups: (1) FSC 500/50 μg Diskus, 1 inhalation twice daily+placebo Handihaler 1 inhalation once-daily daily; (2) tiotropium 18 μg Handihaler, 1 inhalation once daily+placebo Diskus, 1 inhalation twice daily; (3) FSC 500/50 μg Diskus, 1 inhalation twice daily+tiotropium 18 μg Handihaler, 1 inhalation once-daily daily. Patients attended the clinic before and after 1 month, 2 months, and 3 months of treatment for evaluations of pulmonary function, and dyspnea, which was assessed using a visual analog scale (VAS). Also the supplemental salbutamol use was measured. Eighty-one patients completed the 3-month treatment period: 26 patients receiving FSC, 26 patients receiving tiotropium, and 29 patients receiving FSC+tiotropium. Patients were withdrawn for COPD exacerbation. Improvements in trough FEV1 with all treatments medications were observed by the first month when trough FEV1 had improved significantly above baseline by 74 mL (p <0.05) in the tiotropium group, by 117 mL (p <0.05) in the FSC group and by 115 mL (p <0.05) in FSC+tiotropium group. At the end of the study, trough FEV1 had improved significantly above baseline by141 mL (p <0.05) in the tiotropium group, by 140 mL (p <0.05) in the FSC group and by 186 mL (p <0.05) in FSC+tiotropium group. The difference between FSC and tiotropium appeared to decrease, that between FSC and FSC+tiotropium appeared to increase and that between tiotropium and FSC+tiotropium remained almost similar with study duration. Our results suggest that adding FSC and tiotropium may provide benefits in symptomatic patients with severe-to-very severe stable COPD.
KW - Combination therapy
KW - COPD
KW - Dyspnea
KW - Fluticasone propionate
KW - Lung function
KW - Salmeterol
KW - Tiotropium
UR - http://www.scopus.com/inward/record.url?scp=34447498332&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=34447498332&partnerID=8YFLogxK
U2 - 10.1016/j.pupt.2006.06.001
DO - 10.1016/j.pupt.2006.06.001
M3 - Article
C2 - 16914336
AN - SCOPUS:34447498332
VL - 20
SP - 556
EP - 561
JO - Pulmonary Pharmacology and Therapeutics
JF - Pulmonary Pharmacology and Therapeutics
SN - 1094-5539
IS - 5
ER -