Tiotropium/Formoterol Via Discair® vs Tiotropium Monotherapy or Tiotropium + Formoterol Free Combination Treatment
Status:
Completed
Trial end date:
2017-08-01
Target enrollment:
Participant gender:
Summary
The overall objective is to asses the bronchodilator effect of once daily
Tiotropium/Formoterol combination delivered via Discair® by comparing Tiotropium (q.d.)
monotherapy delivered via Handihaler and tiotropium (q.d.) delivered via Handihaler +
formoterol (b.i.d) delivered via Aerolizer free combination treatment in patients with stable
moderate to severe COPD.
Spirometric measurements (FEV1, FVC) will be performed for a period of 24 h at 12 different
times: pre-treatment (15 min prior to the first dose) and post-treatment (30. min, 60 min [1
hr], 120 min [2 hr], 180 min [3 hr], 240 min [4 hr], 360 min [6 hr], 480 min [8 hr], 600 min
[10 hr], 720 min [12 hr], 840 min [14 hr],1440 min [24 hr].