Conditions: COPD
Keywords: COPD
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 30
Healthy volunteers: no

Brief summary:
The purpose of this research study is to determine the amount of medicine absorbed in the lungs following dosing via eFlow nebulizer and Seebri® Breezhaler® with and without activated charcoal in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).

Detailed description:
This is a randomized, open-label, single-dose per dosing period, five-way crossover study in subjects 40 to 70 years of age with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines. After a subject provides consent for study participation, there will be a Screening Period lasting up to 3 weeks to determine study eligibility and to allow for appropriate washout of prohibited medications.

Eligible subjects will be randomized to one of 10 treatment Sequences. There will be a minimum of a 7-day washout period between each treatment visit. At each visit, subjects will receive one dose of study medication according to the sequence assigned.

Subjects with a ≥ 20% decrease in forced expiratory volume in one second (FEV1) based on review of the Visit predose value compared with the Screening value will be evaluated by the investigator for continuation in the study.

Subjects taking theophylline will not be able to participate in the study.

Arms:
arm 1: 50 mcg glycopyrrolate via Electronic Nebulizer arm 2: 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal arm 3: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI arm 4: : : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal arm 5: 50 mcg glycopyrrolate via IV infusion

Interventions: intervention 1: SUN-101 via eFlow nebulizer intervention 2: SUN-101 via eFlow nebulizer with activated charcoal intervention 3: Seebri® Breezhaler® intervention 4: Seebri® Breezhaler® with activated charcoal intervention 5: Glycopyrrolate Injection
Intervention descriptions: intervention 1: 50 mcg glycopyrrolate via Electronic Nebulizer intervention 2: 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal intervention 3: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI intervention 4: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal intervention 5: 50 mcg glycopyrrolate via IV

Protocol document: