Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD Chronic Obstructive Pulmonary Disease Indacaterol QVA149
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 257
Healthy volunteers: no

Brief summary:
An investigational inhalation product (QVA149) for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) is being developed. This 14 day study will investigate the effect on heart rate and cardiovascular effects to ensure the product is safe.

Detailed description:

Arms:
arm 1: Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study. arm 2: One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study. arm 3: One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study. arm 4: One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study. arm 5: Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

Interventions: intervention 1: indacaterol/glycopyrrolate intervention 2: indacaterol intervention 3: glycopyrrolate intervention 4: placebo
Intervention descriptions: intervention 1: Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days. intervention 2: Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days. intervention 3: Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days. intervention 4: Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

Protocol document: