Tiotropium/Salmeterol/Fluticasone Fixed Dose Combination Tratment Via Discair vs Tiotropium Via Handihaler + Salmeterol/Fluticasone Via Diskus Free Combination Treatment
Condition: COPD
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Tiotropium/Salmeterol/Fluticasone 9/50/500 mcg Inhalation Powder; Tiotropium 18 mcg Inhalation Powder; Salmeterol/Fluticasone 50/500 mcg Inhalation Powder
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tiotropium/Salmeterol/Fluticasone 9/50/500 mcg Inhalation Powder (1 puff) twice daily via Discair® for two days.; Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler® for two days.; Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Diskus® for two days
Other intervention name(s): Saltif 9/50/500 mcg Inhalation Powder; Spiriva 18 mcg Inhalation Powder; Seretide Diskus® 500 mcg Inhalation Powder
Intervention MeSH terms: Fluticasone; Xhance; Tiotropium Bromide; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tiotropium; Salmeterol; Fluticasone; COPD; Bronchodilator effect; Discair; Diskus; Spirometry