Conditions: COPD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 616
Healthy volunteers: no

Brief summary:
Neutrophils are thought to play an important role in the pathophysiology of chronic obstructive pulmonary disease (COPD). Navarixin (SCH 527123, MK-7123) is an antagonist of the cysteine-X-cysteine chemokine receptor 2 (CXCR2) and is thought to reduce neutrophil migration to the diseased lung. It is theorized that reducing neutrophil migration to the diseased lung will improve a participant's symptoms and the natural history of the disease.

The study will consist of a 2-week screening period followed by a 2-year (104-week) double-blind treatment period. The 2-year Treatment Period will be made up of two phases: a 26-week (6-month) dose range-finding phase with 3 active arms and 1 placebo arm (Period 1), followed by a 78-week (18-month) long-term safety and efficacy phase (Period 2). Participants participating in the original 6-month study (Period 1) may elect not to continue into the 18-month extension study (Period 2).

Hypothesis: navarixin, 50 mg, or the highest remaining dose if the 50-mg dose is discontinued, is superior to placebo with respect to improving airflow.

Detailed description:

Arms:
arm 1: Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally once daily (QD) for up to 2 years arm 2: Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years arm 3: Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years arm 4: Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years

Interventions: intervention 1: Navarixin intervention 2: Placebo intervention 3: Rescue medication
Intervention descriptions: intervention 1: Navarixin 10 mg and 30 mg capsules intervention 2: Placebo to navarixin capsules intervention 3: Short-acting β-agonist (SABA), anticholinergic, or a combination SABA/anticholinergic

Protocol document: