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Clinical Trials associated with Tiotropium Bromide Monohydrate/Fluticasone Propionate/Salmeterol xinafoateComparison of Bronchodilator Efficacy of Tiotropium/Salmeterol/Fluticasone 9/50/500 mcg Combination Treatment Administered Via Discair® With Original Products Seretide Diskus 500 mcg Inhalation Powder Plus Spiriva 18 mcg Inhalation Powder Treatment in Patients With Moderate-severe Chronic Obstructive Pulmonary Disease (COPD)
The overall objective is to asses the bronchodilator effect of Tiotropium/Salmeterol/Fluticasone combination delivered via Discair® twice daily as compared with original products Seretide Diskus 500 mcg Inhalation Powder twice daily and Spiriva 18 mcg Inhalation Powder once daily free combination treatment in patients with stable moderate to severe COPD.
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.
A Randomized, Open Label, Multicenter, Phase 4 Study for the Comparison of Efficacy of Tiotropium Plus Salmeterol/ Fluticasone Propionate Compared With Tiotropium Alone in COPD Patients
Study title
* A randomized, open label, multicenter, phase 4 study for the comparison of efficacy of tiotropium plus salmeterol/ fluticasone propionate compared with tiotropium alone in COPD patients
Study objectives
* To investigate clinical outcomes of combining tiotropium with fluticasone propionate/salmeterol (FSC) 250/50μg bid compared with tiotropium alone in patients with moderate or severe COPD in Korea
Study Design
* Randomized, open-label, multicenter, parallel-group, two group study
Study assessment
* FEV1
* Inspiratory capacity (IC)
* History of COPD exacerbation
* History of hospitalization for COPD exacerbation and all causes
* QoL (SGRQ-C)
100 Clinical Results associated with Tiotropium Bromide Monohydrate/Fluticasone Propionate/Salmeterol xinafoate
100 Translational Medicine associated with Tiotropium Bromide Monohydrate/Fluticasone Propionate/Salmeterol xinafoate
100 Patents (Medical) associated with Tiotropium Bromide Monohydrate/Fluticasone Propionate/Salmeterol xinafoate
100 Deals associated with Tiotropium Bromide Monohydrate/Fluticasone Propionate/Salmeterol xinafoate