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
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 April 15, 2014