Conditions: Chronic Obstructive Pulmonary Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 99
Healthy volunteers: no

Brief summary:
This is a two-part study conducted at multiple centers, of navarixin (SCH 527123, MK-7123) in participants with moderate to severe chronic obstructive pulmonary disease (COPD). Part 1 of the study is a double-blind, placebo-controlled, randomized, rising-dose study consisting of four treatment groups enrolled in three cohorts. The duration of treatment, for each cohort, will be a 2-week run-in period, followed by a 12-week double-blind treatment period. Treatment initiation for each cohort was staggered by 4 weeks to allow for safety assessment prior to use of higher doses of navarixin. Part 2 of the study will be a double-blind, placebo-controlled, randomized, parallel group study consisting of four treatment groups enrolled as one cohort. The duration of treatment will consist of a 2-week run-in period, followed by a 12-week double-blind treatment period.

Detailed description:

Arms:
arm 1: Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) once daily (QD) for up to 12 weeks arm 2: Cohort 1: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks arm 3: Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks arm 4: Cohort 2: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks arm 5: Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks arm 6: Cohort 3: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks arm 7: Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks arm 8: Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks arm 9: Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks arm 10: Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks

Interventions: intervention 1: Navarixin 1 mg intervention 2: Navarixin 10 mg intervention 3: Placebo to match navarixin intervention 4: Rescue medication
Intervention descriptions: intervention 1: Navarixin 1 mg capsules intervention 2: Navarixin 10 mg capsules intervention 3: Placebo to navarixin capsules intervention 4: Salbutamol/albuterol - 2 puffs of salbutamol/albuterol approximately every 4 hours as needed for dyspnea relief

Protocol document: