This study evaluated the efficacy and safety of two doses of indacaterol in adults aged 40 or over with chronic obstructive pulmonary disease (COPD) in China and in two other countries.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
563
Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
Placebo to indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
Novartis Investigative Site
Adelaide, Australia
Novartis Investigative Site
Clayton, Australia
Novartis Investigative Site
Daw Park, Australia
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.
Time frame: Week 12 + 1 day, Day 85
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Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Changsha, China
Novartis Investigative Site
Chongqing, China
Novartis Investigator Site
Fuzhou, China
Novartis Investigative Site
Guangzhou, China
Novartis Investigative Site
Shandong, China
Novartis Investigative Site
Shanghai, China
...and 5 more locations