Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD indacaterol beta 2 agonist tiotropium
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1598
Healthy volunteers: no

Brief summary:
This study compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.

Detailed description:

Arms:
arm 1: Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication. arm 2: Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.

Interventions: intervention 1: Indacaterol 150 μg intervention 2: Tiotropium 18 μg intervention 3: Placebo to indacaterol intervention 4: Placebo to tiotropium
Intervention descriptions: intervention 1: Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI). intervention 2: Tiotropium 18 μg was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®). intervention 3: Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI). intervention 4: Placebo to tiotropium was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®).

Protocol document: