Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: QVA149 Health related quality of life Formoterol Tiotropium COPD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 934
Healthy volunteers: no

Brief summary:
This study will assess the efficacy and safety of QVA149 compared to tiotropium plus formoterol in patients with moderate to severe COPD.

Detailed description:

Arms:
arm 1: QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use. arm 2: Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.

Interventions: intervention 1: QVA149 intervention 2: Placebo to tiotropium intervention 3: Placebo to formoterol intervention 4: Tiotropium intervention 5: Formoterol intervention 6: Placebo to QVA149
Intervention descriptions: intervention 1: QVA149 110/50µg, once daily (q.d.) is administered via a single-dose dry powder inhaler intervention 2: Placebo to tiotropium capsules daily (q.d.) for inhalation, delivered via proprietary inhaler (Handihaler®). Placebo tiotropium inhalation capsules were matched in size and color to tiotropium 18 μg q.d. inhalation capsules intervention 3: Placebo to formoterol capsules twice daily (b.i.d) delivered via Aerolizer® device. Placebo formoterol inhalation capsules were equally matched in size, shape and color to formoterol 12 μg b.i.d. inhalation capsules. intervention 4: Tiotropium 18µg, once daily is administered via the manufacturer's proprietary inhalation device. intervention 5: Formoterol 12µg, twice daily is administered via the manufacturer's proprietary inhalation device. intervention 6: Placebo to QVA149 is administered via a single-dose dry powder inhaler. Placebo QVA149 inhalation capsules were equally matched in size, shape and color to QVA149 110/50 μg q.d. inhalation capsules

Protocol document: