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NCT00441701Phase 2
Key facts
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.
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
Patients with moderate to severe COPD who are current smokers with at least 10 pack-years history.
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
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)
Beyond the preview
Full results, competitive context and analysis are in the Gosset platform.
Available in the Gosset platform where reported.
Available in the Gosset platform where reported.
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