Conditions: Chronic Obstructive Pulmonary Disease: COPD
Keywords: Moderate to severe COPD patients are included NVA QAB
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 79
Healthy volunteers: no

Brief summary:
The study purpose is to evaluate the effect of QAB149

* NVA237 vs. QAB149 on static lung hyperinflation.

Detailed description:
This is a multicenter, randomized, double-blinded, single-dose, cross-over, placebo-controlled study. The primary endpoint was chosen to demonstrate the superiority of a single-dose of the combined inhalation vs. the mono inhalation regarding the Inspiratory Capacity (IC) peak value. A total of 78 patients will be randomized to complete two visits with two single doses of treatment. Patients will be randomized in a cross-over manner. Treatment visits will be separated by a study medication wash-out period.Treatments will be administered in a blinded fashion.

The patients will be male and female patients, ≥40 years of age, with a documented diagnosis of moderate or severe COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and \>10-pack years history of smoking, FEV1 \<80% and ≥30% of the predicted normal value.

Arms:
arm 1: Patients will inhale QAB149 (capsule form in blister packs) + Placebo via Novartis Concept 1 SDDPI arm 2: Patients will inhale QAB149 plus NVA237 (capsule form in blister packs) via Novartis Concept 1 SDDPI

Interventions: intervention 1: QAB149 intervention 2: Placebo intervention 3: NVA237
Intervention descriptions: intervention 1: Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI intervention 2: Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI intervention 3: Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI

Protocol document: