Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: QVA149, COPD, combination bronchodilator, indacaterol, glycopyrronium bromide
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2144
Healthy volunteers: no

Brief summary:
The purpose of this study is to provide pivotal efficacy and safety data for QVA149 in patients with moderate to severe COPD.

Detailed description:

Arms:
arm 1: QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study. arm 2: NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study. arm 3: QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study. arm 4: Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study. arm 5: Matching placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.

Interventions: intervention 1: indacaterol and glycopyrronium (QVA149) intervention 2: glycopyrronium (NVA237) intervention 3: indacaterol (QAB149) intervention 4: tiotropium intervention 5: placebo
Intervention descriptions: intervention 1: Capsules for inhalation delivered via SDDPI. intervention 2: Capsules for inhalation delivered via SDDPI. intervention 3: Capsules for inhalation delivered via SDDPI. intervention 4: Capsules for inhalation delivered via HandiHaler® device. intervention 5: Placebo to match capsules for inhalation delivered via SDDPI.

Protocol document: