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

October 1, 2009
March 7, 2014
October 2009
March 2011   (final data collection date for primary outcome measure)
  • 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 ]
Pulmonary function test data [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01006616 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Long-Term Study of the Effects of SCH 527123 in Participants With Moderate to Severe COPD (P05575)(MK-7123-019)
A 2-Year, Dose Range-Finding, Adaptive-Design Study of the Effects of SCH 527123 in Subjects With Moderate to Severe COPD

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
COPD
  • Drug: SCH 527123
  • Drug: Placebo
  • Experimental: SCH 527123 10 mg
    SCH 527123 10 mg administered orally once daily for up to 2 years
    Interventions:
    • Drug: SCH 527123
    • Drug: Placebo
  • Experimental: SCH 527123 30 mg
    SCH 527123 30 mg administered orally once daily for up to 2 years
    Interventions:
    • Drug: SCH 527123
    • Drug: Placebo
  • Experimental: SCH 527123 50 mg
    SCH 527123 50 mg administered orally once daily for up to 2 years
    Intervention: Drug: SCH 527123
  • Placebo Comparator: Placebo
    Placebo to match SCH 527123 administered orally once daily for up to 2 years
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
616
November 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
41 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01006616
P05575, 2008-003780-38, MK-7123-019
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP