Conditions: COPD
Keywords: COPD
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 96
Healthy volunteers: no

Brief summary:
Study for subjects 40 to 65 years-old with a diagnosis of moderate to severe COPD. Aclidinium bromide 400 mcg 2x a day will be given as an active comparator.

Detailed description:
This is a randomized, six-way crossover study to determine the efficacy and dose-response profile of SUN101. The study population will consist of subjects 40 to 65 years-old (inclusive), with a diagnosis of moderate to severe COPD. Aclidinium bromide 400 mcg bid will be given as an active comparator. The study will be double-blind for SUN-101 and placebo and will be open-label for aclidinium.

Arms:
arm 1: Placebo bid arm 2: SUN-101 3 mcg bid arm 3: SUN-101 6.25 mcg bid arm 4: SUN-101 12.5 mcg bid arm 5: SUN-101 50 mcg bid arm 6: Aclidinium 400 mcg bid

Interventions: intervention 1: Placebo intervention 2: SUN101 3 mcg intervention 3: SUN-101 6.25 mcg intervention 4: SUN-101 12.5 mcg intervention 5: SUN-101 50 mcg intervention 6: Aclidinium
Intervention descriptions: intervention 1: Placebo intervention 2: SUN-101 3 mcg bid intervention 3: SUN-101 6.25 mcg bid intervention 4: SUN-101 12.5 mcg bid intervention 5: SUN-101 50 mcg bid intervention 6: Aclidinium 400 mcg bid

Protocol document: