This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,732
Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
Formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).
Placebo to indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
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, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Time frame: Week 12 + 1 day, Day 85
Percentage of Days of Poor Control During 52 Weeks of Treatment
Percentage of days of poor control was defined as the number of days in the patient diary with a score ≥ 2 (scale of 0-3, a higher number means more severe symptoms) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness) over 52 weeks divided by the number of evaluable days (days with ≥ 2 symptoms with scores). The analysis included baseline percentage of days of poor control, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Time frame: Baseline to end of study (Week 52)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Placebo to formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).
Novartis Investigator Site
Buenos Aires, Argentina
Novartis
Buenos Aires, Argentina
Novartis Investigator Site
Mendoza, Argentina
Novartis Investigator Site
San Miguel, Argentina
Novartis Investigator Site
Santa Fe, Argentina
Novartis Investigator Site
Rancagua, Chile
Novartis
Santiago, Chile
Novartis Investigator Site
Viña del Mar, Chile
Novartis Investigator Site
Barranquilla, Colombia
Novartis
Bogotá, Colombia
...and 173 more locations