Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD Dyspnea QVA149 tiotropium
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 247
Healthy volunteers: no

Brief summary:
This study assessed the effect of QVA149 on patient-reported dyspnea in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients.

Detailed description:
This study used a multi-center, randomized, blinded, double-dummy placebo controlled, three-period crossover design to assess the effect of once daily QVA149 q.d vs. placebo and tiotropium 18 μg q.d. in terms of patient reported dyspnea as assessed by Baseline Dyspnea Index (BDI)/Transient Dyspnea Index (TDI)(SAC version) in patients with moderate to severe COPD.

Arms:
arm 1: Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication. arm 2: Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication. arm 3: Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.

Interventions: intervention 1: QVA149 intervention 2: Tiotropium intervention 3: Placebo to QVA149 intervention 4: Placebo to tiotropium intervention 5: Salbutamol/albuterol
Intervention descriptions: intervention 1: QVA149 110/50 μg hard non-gelatin capsule, inhalation/blister once a day via SDDPI intervention 2: Tiotropium 18 ug hard gelatin capsule, inhalation/ blister once a day via HandiHaler® device intervention 3: Placebo 0 mg hard non-gelatin capsule, inhalation/ blister once a day via SDDPI intervention 4: Placebo 0 mg hard gelatin capsule, inhalation/ blister once a day via HandiHaler® device intervention 5: salbutamol/albuterol (containing CFC-free propellant -HFA 134a) inhaler used as rescue medication when needed.

Protocol document: