Long-Term Study of the Effects of SCH 527123 in Participants With Moderate to Severe COPD (P05575)(MK-7123-019)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01006616
First received: October 1, 2009
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

Neutrophils are thought to play an important role in the pathophysiology of chronic obstructive pulmonary disease (COPD). SCH 527123 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 participants's symptoms and the natural history of the disease. Hypothesis: SCH 527123, 50 mg, or the highest remaining dose if the 50-mg dose is discontinued, is superior to placebo with respect to improving airflow.


Condition Intervention Phase
COPD
Drug: SCH 527123
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 2-Year, Dose Range-Finding, Adaptive-Design Study of the Effects of SCH 527123 in Subjects With Moderate to Severe COPD

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change from Baseline in post-bronchodilator forced expiratory volume in 1 second (FEV1) [ Time Frame: Baseline and at 26 weeks ] [ Designated as safety issue: No ]
  • Percentage of participants who have an Absolute Neutrophil Count (ANC) of less than 1.5x10^9/L at one or more visits [ Time Frame: Up to 104 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from Baseline in post-bronchodilator FEV1 [ Time Frame: Baseline and at 52 and 104 weeks ] [ Designated as safety issue: No ]
  • Time to first COPD exacerbation [ Time Frame: Up to 104 weeks ] [ Designated as safety issue: No ]
  • COPD exacerbation rate [ Time Frame: At 26, 52 and 104 weeks ] [ Designated as safety issue: No ]
  • Total Exacerbations of Chronic Pulmonary Disease Tool-Patient-Recorded Outcome (EXACT-PRO) questionnaire score [ Time Frame: At 26, 52 and 104 weeks ] [ Designated as safety issue: No ]
  • Sputum neutrophil counts [ Time Frame: At 26, 52 and 104 weeks ] [ Designated as safety issue: No ]
  • St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) score [ Time Frame: At 26, 52 and 104 weeks ] [ Designated as safety issue: No ]
  • Distance walked in 6 minutes (6-minute walk test) [ Time Frame: At 26, 52 and 104 weeks ] [ Designated as safety issue: No ]
  • Pre-bronchodilator FEV1 [ Time Frame: At 26, 52 and 104 weeks ] [ Designated as safety issue: No ]
  • Forced expiratory flow during the middle half of the forced vital capacity (FEF25%-75%) test [ Time Frame: At 26, 52 and 104 weeks ] [ Designated as safety issue: No ]
  • Forced vital capacity (FVC) [ Time Frame: At 26, 52 and 104 weeks ] [ Designated as safety issue: No ]
  • Functional residual capacity (FRC) [ Time Frame: At 26, 52 and 104 weeks ] [ Designated as safety issue: No ]
  • Total lung capacity (TLC) [ Time Frame: At 26, 52 and 104 weeks ] [ Designated as safety issue: No ]
  • Inspiratory capacity (IC) [ Time Frame: At 26, 52 and 104 weeks ] [ Designated as safety issue: No ]
  • Peak expiratory flow (PEF) [ Time Frame: At 26, 52 and 104 weeks ] [ Designated as safety issue: No ]
  • Body-Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) index scores [ Time Frame: At 26, 52 and 104 weeks ] [ Designated as safety issue: No ]
  • Modified Medical Research Council (MMRC) dyspnea score [ Time Frame: At 26, 52 and 104 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in sputum inflammatory markers [ Time Frame: Baseline and at 26, 52 and 104 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in plasma inflammatory biomarkers [ Time Frame: Baseline and at 26, 52 and 104 weeks ] [ Designated as safety issue: No ]
  • Pre- and post-6-minute-walk-test Borg Scale Score [ Time Frame: At 26, 52 and 104 weeks ] [ Designated as safety issue: No ]
  • Percent of arterial oxygen saturation measured by pulse oximetry before/after the 6-minute walk test [ Time Frame: At 26, 52 and 104 weeks ] [ Designated as safety issue: No ]
  • Rate of respiratory infections [ Time Frame: At 26, 52 and 104 weeks ] [ Designated as safety issue: Yes ]
  • Rate of all infections [ Time Frame: At 26, 52 and 104 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 616
Study Start Date: October 2009
Study Completion Date: November 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SCH 527123 10 mg
SCH 527123 10 mg administered orally once daily for up to 2 years
Drug: SCH 527123 Drug: Placebo
Experimental: SCH 527123 30 mg
SCH 527123 30 mg administered orally once daily for up to 2 years
Drug: SCH 527123 Drug: Placebo
Experimental: SCH 527123 50 mg
SCH 527123 50 mg administered orally once daily for up to 2 years
Drug: SCH 527123
Placebo Comparator: Placebo
Placebo to match SCH 527123 administered orally once daily for up to 2 years
Drug: Placebo

  Eligibility

Ages Eligible for Study:   41 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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), eg, sarcoidosis, tuberculosis, pulmonary fibrosis, severe bronchiectasis, or lung cancer.
  • Significant X-ray findings.
  • Use of supplemental oxygen for >12 hours/day.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01006616     History of Changes
Other Study ID Numbers: P05575, 2008-003780-38, MK-7123-019
Study First Received: October 1, 2009
Last Updated: March 7, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 24, 2014