COPD Clinical Trial
Official title:
Comparison 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.
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.
For formerly diagnosed patients who met all the inclusion criteria and receiving COPD
treatment, the day of the screening visit will be based on the completion of a run-in period,
with the length determined by the specific medication. During the run-in period, salbutamol
(100 μg inhaler) will be prescribed as a rescue medication.
Patients (following run-in period for formerly diagnosed patients) will be randomly assigned
to receive Tiotropium/Salmeterol/Fluticasone fixed dose combination as dry powder inhalation
delivered via Discair® twice daily or Seretide Diskus 500 mcg Inhalation Powder twice daily
and Spiriva 18 mcg Inhalation Powder once daily free combination for 2-days treatment period.
Patients will be evaluated at 4 consecutive visits: baseline (enrollment), screening,
treatment and after treatment.
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.
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