Chronic Obstructive Pulmonary DiseasePhase 2NCT00441701
Study to Evaluate the Safety and Dose-Range of Navarixin (SCH 527123, MK-7123) in Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (MK-7123-012)
A Phase 2 study testing Navarixin 1 mg, Navarixin 10 mg and Rescue medication in people with Chronic Obstructive Pulmonary Disease, run by Merck Sharp & Dohme LLC.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 41 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Navarixin 1 mg, Navarixin 10 mg and Rescue medication
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2006to 1 Oct 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of COPD based on the American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria.
- >40 to <=75 years of age, of either sex, and of any race.
- Current smoker with at least 10 pack-years of smoking history (eg, 10 pack-year history is equal to smoking 1 pack of cigarettes per day for 10 years or 2 packs per day for 5 years). Participant will be counseled on the risks of smoking and available smoking cessation programs prior to enrollment. Participant who elects to continue to smoke will be eligible for enrollment. Once enrolled, if a participant elects to discontinue smoking, or reduces cigarette consumption, he/she will be allowed to complete the study.
- History of daily sputum production for at least the past 3 months.
- Post-bronchodilator FEV1 must be >=800 mL, and >=40% to <=70% of predicted FEV1.
- Post-bronchodilator ratio of FEV1 to forced vital capacity (FVC) must be <=70%.
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- Female participants of childbearing potential must be using a medically acceptable, highly effective, adequate form of birth control (ie, failure rate less than 1% per year when used consistently and correctly) prior to Screening and agree to continue using it while in the study (Screening and Treatment Periods). Medically acceptable, highly effective forms of birth control are hormonal implants, oral contraceptives, medically acceptable prescribed intrauterine devices (IUDs), and monogamous relationship with a male partner who has had a vasectomy.
- Female participants should be encouraged to continue using a highly effective method of birth control 30 days following the end of treatment.
- Female participant of child-bearing potential who is not currently sexually active must agree to use a highly effective method of contraception should she become sexually active while participating in the study.
- Male participant must agree to use an adequate form of contraception for the duration of the study and agree to have sexual relations only with women using a highly effective birth control method according to the note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals (CPMP/ICH/286/95 mod).
- 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.
- Female participant who is not of childbearing potential must have a medical record of being surgically sterile (eg, hysterectomy, tubal ligation), or be at least 1 year postmenopausal. Absence of menses for at least 1 year will indicate that a female is postmenopausal.
- Capable of complying with the dosing regimen and visit schedules.
- Willing to give written informed consent to participate in the study.
Who cannot join
- Diagnosed with asthma or other clinically relevant lung disease (other than COPD), eg, sarcoidosis, tuberculosis, pulmonary fibrosis, bronchiectasis, or lung cancer.
- History of previous lung surgery (eg, lobectomy, pneumonectomy, or lung volume reduction).
- Lower respiratory tract infection within 4 weeks prior to the Screening Visit.
- Receiving chronic antibiotic therapy.
- Exacerbation of COPD within the 4 weeks prior to the Screening Visit.
- >20% change at Screening in post-bronchodilator FEV1.
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- Female participant who is breast-feeding, pregnant, or intends to become pregnant during the study.
- Clinically relevant medical conditions (eg, hematologic, cardiovascular, renal, hepatic, neurologic, or metabolic).
- Taken inhaled or systemic steroids within 4 weeks of Screening Visit (Visit 1).
- Received an investigational drug within the last 30 days.
- Produced an inadequate amount of sputum at the Screening Visit (Visit 1) or is known to have difficulty producing sputum.
- PBN count of <3000 cells/microliters at Screening Visit (Visit 1).
- Part of the staff personnel directly involved with this study.
- Family member of the investigational study staff.
- Received any study prohibited medication more recently than the indicated washout period, prior to (Screening), or who must continue to receive any prohibited treatment.
About this study
Official title: Safety and Dose-Ranging Study of the Effects of SCH 527123 in Subjects With Moderate to Severe COPD
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Navarixin 1 mg, Navarixin 10 mg, Placebo to match navarixin, Rescue medication
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navarixin 1 mgDrug
Navarixin 1 mg capsules
Navarixin 10 mgDrug
Navarixin 10 mg capsules
Placebo to match navarixinDrug
Placebo to navarixin capsules
Rescue medicationDrug
Salbutamol/albuterol - 2 puffs of salbutamol/albuterol approximately every 4 hours as needed for dyspnea relief
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Navarixin 1 mg; Drug: Rescue medication |
| Part 1: Placebo to navarixin 3 mg | Placebo comparator | Cohort 1: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks Receives: Drug: Placebo to match navarixin; Drug: Rescue medication |
| 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 Receives: Drug: Navarixin 10 mg; Drug: Placebo to match navarixin; Drug: Rescue medication |
| Part 1: Placebo to navarixin 10 mg | Placebo comparator | Cohort 2: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks Receives: Drug: Placebo to match navarixin; Drug: Rescue medication |
| Part 1: Navarixin 30 mg | Experimental | Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks Receives: Drug: Navarixin 10 mg; Drug: Rescue medication |
| Part 1: Placebo to navarixin 30 mg | Placebo comparator | Cohort 3: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks Receives: Drug: Placebo to match navarixin; Drug: Rescue medication |
| Part 2: Navarixin 3 mg | Experimental | Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks Receives: Drug: Navarixin 1 mg; Drug: Rescue medication |
| 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 Receives: Drug: Navarixin 10 mg; Drug: Placebo to match navarixin; Drug: Rescue medication |
| Part 2: Navarixin 30 mg | Experimental | Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks Receives: Drug: Navarixin 10 mg; Drug: Rescue medication |
| Part 2: Placebo to navarixin | Placebo comparator | Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks Receives: Drug: Placebo to match navarixin; Drug: Rescue medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and the Average over 12 weeks
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.
Measured: Baseline and the Average over 12 weeks
Secondary outcomes (13)
Part 1: Change From Baseline in Percent PBN Count
Participants were to be assessed for percent PBN counts at Baseline and at Week 12.
Measured: Baseline and Week 12
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study start1 Dec 2006
- Primary completion1 Oct 2008
- Study completion1 Oct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441701
- Sponsor's protocol ID
- P04592
- Other IDs
- P04592, 2005-004287-23, 2005
- Status last verified
- Dec 2018
- First submitted
- 28 Feb 2007
- Last updated
- 2 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Dose-Ranging Study of the Effects of SCH 527123 in Subjects With Moderate to Severe COPD
- ClinicalTrials.gov ID
- NCT00441701
- Acronym / sponsor ID
- P04592
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2006 (actual)
- Primary completion
- 1 Oct 2008 (actual)
- Study completion
- 1 Oct 2008 (actual)
- First posted
- 1 Mar 2007 (estimated)
- Results
- Posted 17 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Part 1: Navarixin 3 mg | Experimental | Drug: Navarixin 1 mg, Drug: Rescue medicationCohort 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 | Drug: Placebo to match navarixin, Drug: Rescue medicationCohort 1: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
| Part 1: Navarixin 10 mg | Experimental | Drug: Navarixin 10 mg, Drug: Placebo to match navarixin, Drug: Rescue medicationCohort 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 | Drug: Placebo to match navarixin, Drug: Rescue medicationCohort 2: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
| Part 1: Navarixin 30 mg | Experimental | Drug: Navarixin 10 mg, Drug: Rescue medicationCohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks |
| Part 1: Placebo to navarixin 30 mg | Placebo comparator | Drug: Placebo to match navarixin, Drug: Rescue medicationCohort 3: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
| Part 2: Navarixin 3 mg | Experimental | Drug: Navarixin 1 mg, Drug: Rescue medicationCohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks |
| Part 2: Navarixin 10 mg | Experimental | Drug: Navarixin 10 mg, Drug: Placebo to match navarixin, Drug: Rescue medicationCohort 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 | Drug: Navarixin 10 mg, Drug: Rescue medicationCohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks |
| Part 2: Placebo to navarixin | Placebo comparator | Drug: Placebo to match navarixin, Drug: Rescue medicationCohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks |
Who may qualify
- Ages
- 41 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Diagnosis of COPD based on the American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria.
- >40 to <=75 years of age, of either sex, and of any race.
- Current smoker with at least 10 pack-years of smoking history (eg, 10 pack-year history is equal to smoking 1 pack of cigarettes per day for 10 years or 2 packs per day for 5 years). Participant will be counseled on the risks of smoking and available smoking cessation programs prior to enrollment. Participant who elects to continue to smoke will be eligible for enrollment. Once enrolled, if a participant elects to discontinue smoking, or reduces cigarette consumption, he/she will be allowed to complete the study.
- History of daily sputum production for at least the past 3 months.
- Post-bronchodilator FEV1 must be >=800 mL, and >=40% to <=70% of predicted FEV1.
Key exclusion criteria (15 listed)
- Diagnosed with asthma or other clinically relevant lung disease (other than COPD), eg, sarcoidosis, tuberculosis, pulmonary fibrosis, bronchiectasis, or lung cancer.
- History of previous lung surgery (eg, lobectomy, pneumonectomy, or lung volume reduction).
- Lower respiratory tract infection within 4 weeks prior to the Screening Visit.
- Receiving chronic antibiotic therapy.
- Exacerbation of COPD within the 4 weeks prior to the Screening Visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navarixin 1 mgNavarixin 1 mg capsules | Drug | Part 1: Navarixin 3 mg, Part 2: Navarixin 3 mg |
| Navarixin 10 mgNavarixin 10 mg capsules | Drug | Part 1: Navarixin 10 mg, Part 1: Navarixin 30 mg, Part 2: Navarixin 10 mg, Part 2: Navarixin 30 mg |
| Placebo to match navarixinPlacebo to navarixin capsules | Drug | Part 1: Navarixin 10 mg, Part 1: Placebo to navarixin 10 mg, Part 1: Placebo to navarixin 3 mg, Part 1: Placebo to navarixin 30 mg, Part 2: Navarixin 10 mg, Part 2: Placebo to navarixin |
| Rescue medicationSalbutamol/albuterol - 2 puffs of salbutamol/albuterol approximately every 4 hours as needed for dyspnea relief | Drug | Part 1: Navarixin 10 mg, Part 1: Navarixin 3 mg, Part 1: Navarixin 30 mg, Part 1: Placebo to navarixin 10 mg, Part 1: Placebo to navarixin 3 mg, Part 1: Placebo to navarixin 30 mg, Part 2: Navarixin 10 mg, Part 2: Navarixin 3 mg, Part 2: Navarixin 30 mg, Part 2: Placebo to navarixin |
Primary outcome
Part 1: Number of Participants Who Experience at Least One Adverse Event (AE)
Time frame: Up to 12 weeks
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.
Part 1: Number of Participants Who Discontinue Study Drug Due to an AE
Time frame: Up to 12 weeks
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.
Part 1: Change From Baseline in Absolute Peripheral Blood Neutrophil (PBN) Count
Time frame: Baseline and Week 12
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.
Part 2: Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline and the Average over 12 weeks
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.
Part 2: Change From Baseline in Daily Morning/Nighttime Sputum Production, Cough, and Dyspnea (SCDS) Score
Time frame: Baseline and the Average over 12 weeks
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.
13 secondary outcomes
Part 1: Change From Baseline in Percent PBN Count
Time frame: Baseline and Week 12
Part 1: Change From Baseline in Sputum Absolute Neutrophil Count (Induced Sputum)
Time frame: Baseline and Week 12
Part 1: Change From Baseline in Sputum Percent Neutrophil Count (Induced Sputum)
Time frame: Baseline and Week 12
Part 2: Change From Baseline in Post-Bronchodilator FEV1
Time frame: 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%)
Time frame: Baseline and Week 12
Part 2: Change From Baseline in FVC
Time frame: Baseline and Week 12
Part 2: Change From Baseline in Functional Residual Capacity (FRC)
Time frame: Baseline and Week 12
Part 2: Number of Participants Who Experience a COPD Exacerbation
Time frame: Up to Week 12
Part 2: Change From Baseline in Peak Expiratory Flow (PEF)
Time frame: Baseline and Week 12
Part 2: Change From Baseline in Induced Sputum Absolute Neutrophil Count
Time frame: Baseline and Week 12
Part 2: Change From Baseline in Induced Sputum Percent Neutrophil Count
Time frame: Baseline and Week 12
Part 2: Change From Baseline in Individual Symptom Scores
Time frame: Baseline and Week 12
Part 2: Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Individual/Total Domains
Time frame: Baseline and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Navarixin 1 mg, Navarixin 10 mg and Rescue medication in people with Chronic Obstructive Pulmonary Disease, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Number of Participants Who Experience at Least One Adverse Event (AE) (time frame: Up to 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2019.