Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P04592 | Other Identifier | Merck Protocol Number | |
| 2005-004287-23 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a two-part study conducted at multiple centers, of navarixin (SCH 527123, MK-7123) in participants with moderate to severe chronic obstructive pulmonary disease (COPD). Part 1 of the study is a double-blind, placebo-controlled, randomized, rising-dose study consisting of four treatment groups enrolled in three cohorts. The duration of treatment, for each cohort, will be a 2-week run-in period, followed by a 12-week double-blind treatment period. Treatment initiation for each cohort was staggered by 4 weeks to allow for safety assessment prior to use of higher doses of navarixin. Part 2 of the study will be a double-blind, placebo-controlled, randomized, parallel group study consisting of four treatment groups enrolled as one cohort. The duration of treatment will consist of a 2-week run-in period, followed by a 12-week double-blind treatment period.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Navarixin 3 mg | Experimental | Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) once daily (QD) for up to 12 weeks |
|
| Part 1: Placebo to navarixin 3 mg | Placebo Comparator | Cohort 1: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
|
| Part 1: Navarixin 10 mg | Experimental | Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks |
|
| Part 1: Placebo to navarixin 10 mg | Placebo Comparator | Cohort 2: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
|
| Part 1: Navarixin 30 mg | Experimental | Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navarixin 1 mg | Drug | Navarixin 1 mg capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants Who Experience at Least One Adverse Event (AE) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. The number of participants who experienced an AE, regardless of causality or severity, was summarized. | Up to 12 weeks |
| Part 1: Number of Participants Who Discontinue Study Drug Due to an AE | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. The number of participants who discontinued study drug, whether permanently or temporarily, due to an AE was summarized. | Up to 12 weeks |
| Part 1: Change From Baseline in Absolute Peripheral Blood Neutrophil (PBN) Count | Participants were assessed for absolute PBN counts at Baseline and Week 12. The reported standard deviations (SDs) are pooled across all treatment groups. The rationale for the use of an analysis of variance (ANOVA) method using pooled SD values is the assumption that the SDs are similar across treatment groups. | Baseline and Week 12 |
| Part 2: Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) | FEV1, as measured in liters via spirometry, is a measure of the amount of air expired in 1 second. Participants were to be assessed for pre-bronchodilator FEV1 immediately before dosing with bronchodilator (albuterol sulfate or equivalent) at Baseline and at Week 12. Pre-bronchodilator FEV1 data were to be averaged weekly over the 12-week treatment period for analysis. | Baseline and the Average over 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Change From Baseline in Percent PBN Count | Participants were to be assessed for percent PBN counts at Baseline and at Week 12. | Baseline and Week 12 |
| Part 1: Change From Baseline in Sputum Absolute Neutrophil Count (Induced Sputum) |
Not provided
Inclusion Criteria:
Female participants should be encouraged to continue using a highly effective method of birth control 30 days following the end of treatment.
A highly effective method of birth control is defined as that which results in a low failure rate (ie, less that 1% per year) when used consistently and correctly, such as hormonal implants, injectables, combined oral contraceptives, hormonal IUDs.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
Not provided
Not provided
Not provided
| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Navarixin 3 mg | Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) once daily (QD) for up to 12 weeks |
| FG001 | Part 1: Placebo to Navarixin 3 mg | Cohort 1: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Part 1: Placebo to navarixin 30 mg | Placebo Comparator | Cohort 3: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
|
| Part 2: Navarixin 3 mg | Experimental | Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks |
|
| Part 2: Navarixin 10 mg | Experimental | Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks |
|
| Part 2: Navarixin 30 mg | Experimental | Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks |
|
| Part 2: Placebo to navarixin | Placebo Comparator | Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
|
| Navarixin 10 mg | Drug | Navarixin 10 mg capsules |
|
| Placebo to match navarixin | Drug | Placebo to navarixin capsules |
|
| Rescue medication | Drug | Salbutamol/albuterol - 2 puffs of salbutamol/albuterol approximately every 4 hours as needed for dyspnea relief |
|
| Part 2: Change From Baseline in Daily Morning/Nighttime Sputum Production, Cough, and Dyspnea (SCDS) Score | Participants were to assess their morning (AM) and nighttime (PM) COPD symptoms (sputum production, cough, and dyspnea) on a daily basis in their e-Diaries. Baseline SCDS was defined as the average of AM and PM values over the week prior to and including Day 1 (AM) prior to the first dose of study drug. SCDS data were to be averaged weekly over the 12-week treatment period for analysis. | Baseline and the Average over 12 weeks |
Participants were assessed for induced sputum absolute neutrophil counts via the nebulized method at Baseline and at Week 12. The reported SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.
| Baseline and Week 12 |
| Part 1: Change From Baseline in Sputum Percent Neutrophil Count (Induced Sputum) | Sputum neutrophils were to be measured as percent of total white blood cells. Participants were to be assessed for induced sputum percent neutrophil counts via the nebulized method at Baseline and at Week 12. | Baseline and Week 12 |
| Part 2: Change From Baseline in Post-Bronchodilator FEV1 | FEV1, as measured in liters via spirometry, is a measure of the amount of air expired in 1 second. Participants were to be assessed for post-bronchodilator FEV1 30 minutes after dosing with bronchodilator (albuterol sulfate or equivalent) (reversibility test) at Baseline and Week 12. Post-bronchodilator data were to be averaged weekly over the 12-week treatment period for analysis. | Baseline and the Average over 12 weeks |
| Part 2: Change From Baseline in Forced Expiratory Flow During Middle Half of Forced Vital Capacity (FVC) (FEF25%-75%) | Mid-Breath Forced Expiratory Flow (FEF25%-75%), as measured in liters/minute via spirometry, is the rate at which participants breathe out air from 25 percent of their breath to 75 percent of their breath. Participants were to be assessed for FEF25%-75% at Baseline and Week 12. | Baseline and Week 12 |
| Part 2: Change From Baseline in FVC | FVC, as measured in liters via spirometry, is the amount of air forcibly exhaled from the lungs after taking the deepest breath possible. Post-bronchodilator FVC was to be assessed 30 minutes after bronchodilator administration at Baseline and Week 12. | Baseline and Week 12 |
| Part 2: Change From Baseline in Functional Residual Capacity (FRC) | FRC, as measured in liters via body plethysmography, is the volume of air present in the lungs, specifically the parenchyma tissues, at the end of passive expiration. Participants were to be assessed for FRC at Baseline and Week 12. | Baseline and Week 12 |
| Part 2: Number of Participants Who Experience a COPD Exacerbation | COPD exacerbation is defined as any change in symptoms or functional status that leads to administration of systemic corticosteroids, antibiotics, an emergency room visit or a hospitalization. The number of participants who experienced a COPD exacerbation was to be summarized. | Up to Week 12 |
| Part 2: Change From Baseline in Peak Expiratory Flow (PEF) | PEF, as measured in liters/minute via peak flow meter, is the maximum speed of expiration. Participants were to measure their PEF in triplicate every morning before taking study drug and again every evening. | Baseline and Week 12 |
| Part 2: Change From Baseline in Induced Sputum Absolute Neutrophil Count | Participants were to be assessed for induced sputum absolute neutrophil counts via the nebulized method at Baseline and at Week 12. | Baseline and Week 12 |
| Part 2: Change From Baseline in Induced Sputum Percent Neutrophil Count | Sputum neutrophils were to be measured as percent of total white blood cells. Participants were to be assessed for induced sputum percent neutrophil counts via the nebulized method at Baseline and at Week 12. | Baseline and Week 12 |
| Part 2: Change From Baseline in Individual Symptom Scores | Participants were to be assessed for individual symptom scores at Baseline and Week 12 using the following scales: Sputum Production (0=none, unaware of any sputum production to 4=severe, an almost constant problem), Cough (0=none, unaware of coughing to 4=severe, never free of cough or need to cough), and Dyspnea (0=none, unaware of any difficulty to 4=severe, almost constant: present even when resting). | Baseline and Week 12 |
| Part 2: Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Individual/Total Domains | SGRQ consists of 76 items aggregated into 3 domain scores: Symptoms (frequency/severity), Activity (cause or limited by breathlessness), Impact (social functioning, psychological disturbances from airway disease), and total score. Participants were to assess their symptoms, activity and impact at Baseline and Week 12. | Baseline and Week 12 |
| FG002 | Part 1: Navarixin 10 mg | Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks |
| FG003 | Part 1: Placebo to Navarixin 10 mg | Cohort 2: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
| FG004 | Part 1: Navarixin 30 mg | Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks |
| FG005 | Part 1: Placebo to Navarixin 30 mg | Cohort 3: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
| FG006 | Part 2: Navarixin 3 mg | Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks |
| FG007 | Part 2: Navarixin 10 mg | Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks |
| FG008 | Part 2: Navarixin 30 mg | Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks |
| FG009 | Part 2: Placebo to Navarixin | Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Navarixin 3 mg | Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks |
| BG001 | Part 1: Placebo to Navarixin 3 mg | Cohort 1: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
| BG002 | Part 1: Navarixin 10 mg | Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks |
| BG003 | Part 1: Placebo to Navarixin 10 mg | Cohort 2: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
| BG004 | Part 1: Navarixin 30 mg | Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks |
| BG005 | Part 1: Placebo to Navarixin 30 mg | Cohort 3: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
| BG006 | Part 2: Navarixin 3 mg | Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks |
| BG007 | Part 2: Navarixin 10 mg | Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks |
| BG008 | Part 2: Navarixin 30 mg | Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks |
| BG009 | Part 2: Placebo to Navarixin | Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
| BG010 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part 1: Number of Participants Who Experience at Least One Adverse Event (AE) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. The number of participants who experienced an AE, regardless of causality or severity, was summarized. | The population consisted of all Part 1 participants who were randomized and received at least one dose of study drug. | Posted | Number | Participants | Up to 12 weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Part 1: Number of Participants Who Discontinue Study Drug Due to an AE | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. The number of participants who discontinued study drug, whether permanently or temporarily, due to an AE was summarized. | The population consisted of all Part 1 participants who were randomized and received at least one dose of study drug. | Posted | Number | Participants | Up to 12 weeks |
| |||||||||||||||||||||||||||||||||||||
| Primary | Part 1: Change From Baseline in Absolute Peripheral Blood Neutrophil (PBN) Count | Participants were assessed for absolute PBN counts at Baseline and Week 12. The reported standard deviations (SDs) are pooled across all treatment groups. The rationale for the use of an analysis of variance (ANOVA) method using pooled SD values is the assumption that the SDs are similar across treatment groups. | The population consisted of all Part 1 participants who were randomized and received at least one dose of study drug and had a Baseline and a Week 12 assessment for absolute PBN count. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline and Week 12 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Part 2: Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) | FEV1, as measured in liters via spirometry, is a measure of the amount of air expired in 1 second. Participants were to be assessed for pre-bronchodilator FEV1 immediately before dosing with bronchodilator (albuterol sulfate or equivalent) at Baseline and at Week 12. Pre-bronchodilator FEV1 data were to be averaged weekly over the 12-week treatment period for analysis. | The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and at least one post-Baseline assessment for FEV1. Part 2 of this study was not conducted under this protocol. | Posted | Baseline and the Average over 12 weeks |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Part 2: Change From Baseline in Daily Morning/Nighttime Sputum Production, Cough, and Dyspnea (SCDS) Score | Participants were to assess their morning (AM) and nighttime (PM) COPD symptoms (sputum production, cough, and dyspnea) on a daily basis in their e-Diaries. Baseline SCDS was defined as the average of AM and PM values over the week prior to and including Day 1 (AM) prior to the first dose of study drug. SCDS data were to be averaged weekly over the 12-week treatment period for analysis. | The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and at least one post-Baseline assessment for AM/PM SCDS scores. Part 2 of this study was not conducted under this protocol. | Posted | Baseline and the Average over 12 weeks |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Part 1: Change From Baseline in Percent PBN Count | Participants were to be assessed for percent PBN counts at Baseline and at Week 12. | The population was to consist of all Part 1 participants who were randomized, received at least one dose of study drug, and had a Baseline and a Week 12 assessment for percent PBN count. Since sufficient data for analysis were collected for absolute PBN count, percent PBN count was not assessed. | Posted | Baseline and Week 12 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Part 1: Change From Baseline in Sputum Absolute Neutrophil Count (Induced Sputum) | Participants were assessed for induced sputum absolute neutrophil counts via the nebulized method at Baseline and at Week 12. The reported SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups. | The population consisted of all Part 1 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 assessment for induced sputum absolute neutrophil count. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline and Week 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Part 1: Change From Baseline in Sputum Percent Neutrophil Count (Induced Sputum) | Sputum neutrophils were to be measured as percent of total white blood cells. Participants were to be assessed for induced sputum percent neutrophil counts via the nebulized method at Baseline and at Week 12. | The population was to consist of all Part 1 participants who were randomized, received at least 1 dose of study drug, and had a Baseline and Week 12 assessment for sputum percent neutrophil count. Since sufficient data for analysis were collected for absolute sputum neutrophil count, percent sputum neutrophil count was not assessed. | Posted | Baseline and Week 12 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Change From Baseline in Post-Bronchodilator FEV1 | FEV1, as measured in liters via spirometry, is a measure of the amount of air expired in 1 second. Participants were to be assessed for post-bronchodilator FEV1 30 minutes after dosing with bronchodilator (albuterol sulfate or equivalent) (reversibility test) at Baseline and Week 12. Post-bronchodilator data were to be averaged weekly over the 12-week treatment period for analysis. | The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 efficacy assessment for post-bronchodilator FEV1. Part 2 of this study was not conducted under this protocol. | Posted | Baseline and the Average over 12 weeks |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Change From Baseline in Forced Expiratory Flow During Middle Half of Forced Vital Capacity (FVC) (FEF25%-75%) | Mid-Breath Forced Expiratory Flow (FEF25%-75%), as measured in liters/minute via spirometry, is the rate at which participants breathe out air from 25 percent of their breath to 75 percent of their breath. Participants were to be assessed for FEF25%-75% at Baseline and Week 12. | The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 assessment for FEF25%-75%. Part 2 of this study was not conducted under this protocol. | Posted | Baseline and Week 12 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Change From Baseline in FVC | FVC, as measured in liters via spirometry, is the amount of air forcibly exhaled from the lungs after taking the deepest breath possible. Post-bronchodilator FVC was to be assessed 30 minutes after bronchodilator administration at Baseline and Week 12. | The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 efficacy assessment for FVC. Part 2 of this study was not conducted under this protocol. | Posted | Baseline and Week 12 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Change From Baseline in Functional Residual Capacity (FRC) | FRC, as measured in liters via body plethysmography, is the volume of air present in the lungs, specifically the parenchyma tissues, at the end of passive expiration. Participants were to be assessed for FRC at Baseline and Week 12. | The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 efficacy assessment for FRC. Part 2 of this study was not conducted under this protocol. | Posted | Baseline and Week 12 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Number of Participants Who Experience a COPD Exacerbation | COPD exacerbation is defined as any change in symptoms or functional status that leads to administration of systemic corticosteroids, antibiotics, an emergency room visit or a hospitalization. The number of participants who experienced a COPD exacerbation was to be summarized. | The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a at least one post-Baseline assessment for presence of COPD exacerbation. Part 2 of this study was not conducted under this protocol. | Posted | Up to Week 12 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Change From Baseline in Peak Expiratory Flow (PEF) | PEF, as measured in liters/minute via peak flow meter, is the maximum speed of expiration. Participants were to measure their PEF in triplicate every morning before taking study drug and again every evening. | The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 efficacy assessment for PEF. Part 2 of this study was not conducted under this protocol. | Posted | Baseline and Week 12 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Change From Baseline in Induced Sputum Absolute Neutrophil Count | Participants were to be assessed for induced sputum absolute neutrophil counts via the nebulized method at Baseline and at Week 12. | The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug and had a Baseline and Week 12 assessment for induced sputum absolute neutrophil count. Part 2 of this study was not conducted under this protocol. | Posted | Baseline and Week 12 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Change From Baseline in Induced Sputum Percent Neutrophil Count | Sputum neutrophils were to be measured as percent of total white blood cells. Participants were to be assessed for induced sputum percent neutrophil counts via the nebulized method at Baseline and at Week 12. | The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug and had a Baseline and Week 12 assessment for sputum percent neutrophil count. Part 2 of this study was not conducted under this protocol. | Posted | Baseline and Week 12 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Change From Baseline in Individual Symptom Scores | Participants were to be assessed for individual symptom scores at Baseline and Week 12 using the following scales: Sputum Production (0=none, unaware of any sputum production to 4=severe, an almost constant problem), Cough (0=none, unaware of coughing to 4=severe, never free of cough or need to cough), and Dyspnea (0=none, unaware of any difficulty to 4=severe, almost constant: present even when resting). | The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug and had a Baseline and Week 12 efficacy assessment for individual symptom scores. Part 2 of this study was not conducted under this protocol. | Posted | Baseline and Week 12 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Individual/Total Domains | SGRQ consists of 76 items aggregated into 3 domain scores: Symptoms (frequency/severity), Activity (cause or limited by breathlessness), Impact (social functioning, psychological disturbances from airway disease), and total score. Participants were to assess their symptoms, activity and impact at Baseline and Week 12. | The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug and had a Baseline and Week 12 efficacy assessment for SGRQ. Part 2 of this study was not conducted under this protocol. | Posted | Baseline and Week 12 |
|
Up to 30 days after last dose of study drug (Up to 16 weeks)
Part 2 was not conducted under this protocol.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: Navarixin 3 mg | Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks | 1 | 22 | 8 | 22 | ||
| EG001 | Part 1: Navarixin 10 mg | Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks | 1 | 22 | 8 | 22 | ||
| EG002 | Part 1: Navarixin 30 mg | Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks | 1 | 22 | 7 | 22 | ||
| EG003 | Part 1: Placebo to Navarixin (Pooled) | Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks | 4 | 33 | 10 | 33 | ||
| EG004 | Part 2: Navarixin 3 mg | Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks | 0 | 0 | 0 | 0 | ||
| EG005 | Part 2: Navarixin 10 mg | Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks | 0 | 0 | 0 | 0 | ||
| EG006 | Part 2: Navarixin 30 mg | Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks | 0 | 0 | 0 | 0 | ||
| EG007 | Part 2: Placebo to Navarixin | Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Congestive cardiomyopathy | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Rectal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Alcohol abuse | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Toothache | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
The investigator agrees to provide the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including, without limitation, slides and texts of oral or other public presentations and texts of any transmission through any electronic media, eg, any computer access system such as the Internet, World Wide Web, etc.) that report any results of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000730055 | navarixin |
Not provided
Not provided
Not provided
| Male |
|
| Part 1: Placebo to Navarixin (Pooled) |
Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
|
|
| Part 1: Placebo to Navarixin (Pooled) |
Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
|
|
| OG003 | Part 2: Placebo to Navarixin | Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
|
| OG003 | Part 2: Placebo to Navarixin | Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
|
|
| Part 1: Placebo to Navarixin (Pooled) |
Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
|
|
| Part 1: Placebo to Navarixin (Pooled) |
Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
|
| OG003 | Part 2: Placebo to Navarixin | Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
|
| Part 2: Placebo to Navarixin |
Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
|
Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
|
Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
|
Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
|
Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
|
Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
|
Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
|
| OG003 | Part 2: Placebo to Navarixin | Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
|
| Part 2: Placebo to Navarixin |
Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
|