Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: respiratory dyspnea breathlessness COPD indacaterol long-acting β2-agonist
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1123
Healthy volunteers: no

Brief summary:
This study compared the safety and efficacy of indacaterol 150 µg taken once daily (o.d.) versus salmeterol 50 µg taken twice daily (b.i.d) in patients 40 years old or older with chronic obstructive pulmonary disease.

Detailed description:

Arms:
arm 1: Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, \[DISKUS\]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 2: Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, \[DISKUS\]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Interventions: intervention 1: Indacaterol 150 µg intervention 2: Salmeterol 50 µg intervention 3: Placebo to indacaterol intervention 4: Placebo to salmeterol
Intervention descriptions: intervention 1: Indacaterol 150 μg was provided in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI). intervention 2: Salmeterol 50 μg was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, \[DISKUS\]). intervention 3: Placebo to indacaterol was provided in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI). intervention 4: Placebo to salmeterol was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, \[DISKUS\]).

Protocol document: