Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic obstructive pulmonary disease, indacaterol, salmeterol, placebo controlled
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1002
Healthy volunteers: no

Brief summary:
This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.

Detailed description:

Arms:
arm 1: Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. arm 2: Placebo to Indacaterol once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. arm 3: Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI).

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) 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 once daily (o.d) inhaled intervention 2: Salmeterol 50 μg twice daily (b.i.d) delivered via a proprietary dry powder inhaler intervention 3: Placebo to Indacaterol inhaled via SDDPI. intervention 4: Placebo to salmeterol delivered via a proprietary dry powder inhaler

Protocol document: