Long-Term Study of the Effects of Navarixin (SCH 527123, MK-7123) in Participants With Moderate to Severe COPD (MK-7123-019)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: COPD

Treatments: Drug: Navarixin; Drug: Placebo; Drug: Rescue medication

Study type: Interventional

Funder types: Industry

Identifiers

NCT01006616

P05575 (Other Identifier)

2008-003780-38 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 616 patients

Sex: All

Ages: 41 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of COPD for at least 2 years based on American Thoracic Society/European Respiratory Society (ATS/ERS) current guidelines or symptoms consistent with COPD for at least 2 years.
• >40 to <=75 years of age, of either sex, and of any race.
• No exacerbation or respiratory infection in the past 6 weeks.
• Smoker or ex-smoker with more than 10 pack-year history.

Exclusion criteria

• Diagnosis of asthma or other clinically relevant lung disease (other than COPD), i.e., sarcoidosis, tuberculosis, pulmonary fibrosis, severe bronchiectasis, or lung cancer.
• Significant X-ray findings.
• Use of supplemental oxygen for >12 hours/day.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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616 participants in 4 patient groups, including a placebo group

Navarixin 10 mg

Experimental group

Description:

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

Treatment:

Drug: Rescue medication

Drug: Navarixin

Drug: Placebo

Navarixin 30 mg

Experimental group

Description:

Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years

Treatment:

Drug: Rescue medication

Drug: Navarixin

Drug: Placebo

Navarixin 50 mg

Experimental group

Description:

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

Treatment:

Drug: Rescue medication

Drug: Navarixin

Placebo

Placebo Comparator group

Description:

Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years

Treatment:

Drug: Rescue medication

Drug: Placebo