Conditions: COPD
Keywords: COPD, early morning symptoms
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 124
Healthy volunteers: no

Brief summary:
This study purpose is to further study the profiles of glycopyrronium (NVA237) and tiotropium during the first hours after dosing and their impact on pulmonary function, COPD symptoms and ability to perform daily activities by the patient.

Detailed description:
Randomized, multicenter, blinded, two-period cross-over design. Each treatment will last 28 days. All patients will receive both treatments in a cross-over design, with a wash-out period of 14-19 days in between. The total duration of the study for each patient is approximately 70 days (from randomization) plus 30 days of safety follow-up.

Arms:
arm 1: Participants will receive sequence A = glycopyrronium + placebo to tiotropium during 28 days, followed by a 14 day washout period, then sequence B= tiotropium + placebo to glycopyrronium for 28 days. arm 2: Participants will receive sequence B= tiotropium + placebo to glycopyrronium during 28 days, followed by a 14 day washout period, then sequence A= glycopyrronium + placebo to tiotropium for 28 days.

Interventions: intervention 1: Glycopyrronium intervention 2: Tiotropium intervention 3: Placebo to glycopyrronium intervention 4: Placebo to tiotropium
Intervention descriptions: intervention 1: Glycopyrronium capsule for inhalation once per day via SDDPI intervention 2: Tiotropium capsule for inhalation once per day via HandiHaler® device intervention 3: Placebo to glycopyrronium capsule for inhalation once per day via SDDPI intervention 4: Placebo to tiotropium capsule for inhalation once per day via HandiHaler® device

Protocol document: