This study compared the effects of a single dose of indacaterol with that of a single dose of tiotropium on inspiratory capacity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Novartis Investigative Site
Bergamo, Italy
Novartis Investigative Site
Brescia, Italy
Novartis Investigative Site
Cava de' Tirreni, Italy
Novartis Investigative Site
Genova, Italy
Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment
During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured 3 times each at 30, 60, 120, 180, and 240 minutes post-dose and the highest value was reported in liters.
Time frame: 4 hour period following inhalation of study treatment
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.
Time frame: 4 hour period following inhalation of study treatment
Force Vital Capacity (FVC) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment
FVC was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.
Time frame: 4 hour period following inhalation of study treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novartis Investigative Site
Milan, Italy
Novartis Investigative Site
Orbassano, Italy
Novartis Investigative Site
Pavia, Italy
Novartis Investigative Site
Reggio Emilia, Italy
Novartis Investigative Site
Sesto San Giovanni, Italy
Novartis Investigative Site
Treviso, Italy
...and 1 more locations