Trial intelligence / Profile preview

Navarixin in Moderate to Severe COPD

NCT00441701Phase 2

Key facts

Status
Terminated
Start
Dec 2006
Primary completion
Oct 2008
Modality
Small Molecules
Conditions
chronic obstructive pulmonary disease (COPD)
01

Overview

Phase 2, randomised, double-blind trial of navarixin in chronic obstructive pulmonary disease (COPD) (4 arms), sponsored by Merck & Co. Primary endpoints: Number of Participants Who Experience at Least One Adverse Event (AE) at 12 weeks, Number of Participants Who Discontinue Study Drug Due to an AE at 12 weeks and 3 more. Started Dec 2006; status: terminated.

02

Design

4 arms
Study design
RandomizedDouble-blind
  • Navarixin 3 mg

    Navarixin 3 mg QD

  • Navarixin 10 mg

    Navarixin 10 mg QD

  • Navarixin 30 mg

    Navarixin 30 mg QD

  • Placebo

    Placebo to match navarixin

03

Who it enrols

Patients with moderate to severe COPD who are current smokers with at least 10 pack-years history.

04

Endpoints

Primary

  • Number of Participants Who Experience at Least One Adverse Event (AE)

  • Number of Participants Who Discontinue Study Drug Due to an AE

  • Change From Baseline in Absolute Peripheral Blood Neutrophil (PBN) Count

  • Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

  • Change From Baseline in Daily Morning/Nighttime Sputum Production, Cough, and Dyspnea (SCDS) Score

Secondary

  • Change From Baseline in Percent PBN Count

  • Change From Baseline in Sputum Absolute Neutrophil Count (Induced Sputum)

  • Change From Baseline in Post-Bronchodilator FEV1

  • Change From Baseline in Forced Expiratory Flow During Middle Half of Forced Vital Capacity (FVC) (FEF25%-75%)

  • Change From Baseline in FVC

  • Change From Baseline in Functional Residual Capacity (FRC)

  • Number of Participants Who Experience a COPD Exacerbation

  • Change From Baseline in Peak Expiratory Flow (PEF)

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