The study compared the 24-hour spirometry profile of indacaterol with that of placebo and with tiotropium as an active control in patients with chronic obstructive pulmonary disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
169
Indacaterol 150 μg or 300 μg, delivered via SDDPI
Tiotropium 18 μg once daily delivered via inhalation device
Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium manufacturer's proprietary inhalation device (HandiHaler®)
Novartis Investigative site
Camperdown, Australia
Novartis Investigator Site
Gauting, Germany
24-hour Post-dose Trough Forced Expiratory Volume in 1 Second (FEV1) After 14 Days of Treatment
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the mean of FEV1 measurements at 23 h 10 min and 23 h 45 min post Day 14 dose measured on the morning of Day 15 in each treatment period. The model used for analysis contained the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.
Time frame: 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 15 of each treatment period
Peak FEV1 During 4 Hours Post Morning Dose on Day 1
FEV1 was measured with spirometry conducted according to internationally accepted standards. The peak effect on Day 1 was defined as the maximum FEV1 during the first 4 hour on that day. FEV1 measurements taken within 6 hour of rescue use were set to missing before the peak FEV1 (0-4 hour) was calculated. The model used for analysis contained the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.
Time frame: Day 1 (from 0 to 4 hours post morning dose)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novartis Investigator Site
Großhansdorf, Germany
Novartis Investigator Site
Mainz, Germany
Novartis Investigator site
Marburg, Germany
Novartis Investigator Site
Wiesbaden, Germany
Novartis Investigator Site
Almelo, Netherlands
Novartis Investigator Site
Breda, Netherlands
Novartis Investigator Site
Eindhoven, Netherlands
Novartis Investigator Site
Harderwijk, Netherlands
...and 10 more locations