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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-005615-26 | EudraCT Number | ||
| P05365 | Other Identifier | Merck protocol number |
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4-Week Safety Study in Subjects with Neutrophilic Asthma
Effect of treatment with navarixin (MK-7123, SCH 527123) on sputum neutrophils and asthma symptoms
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Navarixin | Experimental | Navarixin (MK-7123, SCH 527123) 30 mg capsule, to be taken by mouth once daily in the morning for 4 weeks |
|
| Placebo | Placebo Comparator | Placebo capsule to match navarixin, to be taken by mouth once daily in the morning for 4 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navarixin | Drug | Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Maintained an Absolute Peripheral Blood Neutrophil Count >=1500/µL | Peripheral blood neutrophil counts were performed on Day 2 and Weeks 1, 2, 3, and 4 of the treatment period | Up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Sputum Absolute Neutrophil Count | Induced sputum samples were obtained at Baseline and at Weeks 2 and 4 of the treatment period. Samples were collected before study drug administration using the nebulizer method and sent to a central laboratory for analysis. An average was taken over all post-baseline samples collected no later than one day after the last dose of study drug. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22702508 | Result | Nair P, Gaga M, Zervas E, Alagha K, Hargreave FE, O'Byrne PM, Stryszak P, Gann L, Sadeh J, Chanez P; Study Investigators. Safety and efficacy of a CXCR2 antagonist in patients with severe asthma and sputum neutrophils: a randomized, placebo-controlled clinical trial. Clin Exp Allergy. 2012 Jul;42(7):1097-103. doi: 10.1111/j.1365-2222.2012.04014.x. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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Participants were considered to complete the study if they completed the follow-up visit, whether or not they completed treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Navarixin | Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks |
| FG001 | Placebo | Placebo capsule to be taken by mouth once daily for 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
All randomized participants who received study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Navarixin | Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks |
| BG001 | Placebo | Placebo capsule to be taken by mouth once daily for 4 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants Who Maintained an Absolute Peripheral Blood Neutrophil Count >=1500/µL | Peripheral blood neutrophil counts were performed on Day 2 and Weeks 1, 2, 3, and 4 of the treatment period | The analysis population included all participants who received at least one dose of study drug | Posted | Number | Number of participants | Up to 4 weeks |
|
Up to 5 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Navarixin | Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| C000730055 | navarixin |
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| Placebo | Drug | Placebo capsule to match navarixin to be taken by mouth once daily in the morning for 4 weeks. |
|
| Rescue medication | Drug | Participant choice of short-acting beta-2 agonist (salbutamol/albuterol), anticholinergic, or combination medication as needed for asthma symptoms |
|
| Baseline and while on study drug (up to 4 weeks) |
| Mean Change From Baseline in Total Asthma Symptom Score | Total Asthma Symptom Score is the sum of individual symptoms of wheezing, coughing, and dyspnea assessed twice daily (morning and evening) and is recorded on a comment diary card. Each of the symptoms receives a daily score from 0 (none) to 3 (severe), averaged over the two daily assessments. The total score ranges from 0 to 9, with a lower score indicating less severe asthma symptoms. | Baseline and Weeks 1, 2, 3, and 4 |
| Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second (FEV1) | Spirometry was used to measure post-bronchodilator FEV1 at Baseline and before study drug administration at Weeks 1, 2, 3, and 4. Participants received 4 puffs of bronchodilator (salbutamol hydrofluoroalkane or equivalent) at 30-second intervals and spirometry was performed 30 minutes later. The mean change from baseline is based on the average change over all post-baseline assessments. | Baseline and up to 4 weeks |
| Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) | The AQLQ[S] was administered at Baseline and at Weeks 2 and 4. The assessment consists of a 32-item questionnaire covering 4 domains: symptoms, emotional functioning, impact of environmental stimuli, and activity limitation. Each item receives a score from 1 (worst, or most affected) to 7 (not at all affected). The score is the mean across all items, and ranges from 1 to 7. The mean change from baseline is based on the average change over all post-baseline assessments. | Baseline and up to 4 weeks |
| Number of Participants With an Adverse Event (AE) | An AE is any untoward medical occurrence in a participant administered study drug 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. | Up to 5 weeks |
| Number of Participants With an Electrocardiogram Adverse Event | The endpoint measured was any electrocardiogram abnormality that was reported as an AE. An AE is any untoward medical occurrence in a participant administered study drug 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. | Week 4 |
| Number of Participants With a Laboratory Adverse Event | The endpoint measured was any laboratory (hematology, blood chemistry, or urinalysis) abnormality that was reported as an AE. An AE is any untoward medical occurrence in a participant administered study drug 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. | Up to 5 weeks |
| Number of Participants Who Discontinued the Study Because of an Adverse Event | An AE is any untoward medical occurrence in a participant administered study drug 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. | Up to 5 weeks |
| Number of Participants Who Discontinued Treatment Because of an Adverse Event or a Protocol-defined Clinical Event | An AE is any untoward medical occurrence in a participant administered study drug 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. A protocol-defined clinical event is an asthma exacerbation requiring addition of or increase in systemic steroids, as determined by the investigator. | Up to 4 weeks |
| Maximum Plasma Concentration of Navarixin (Cmax) | Plasma samples were to be collected at baseline and up to 24 hours after dosing with navarixin at Weeks 1, 2, 3, and 4 | Week 1, 2, 3, and 4 |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Mean Change From Baseline in Sputum Absolute Neutrophil Count | Induced sputum samples were obtained at Baseline and at Weeks 2 and 4 of the treatment period. Samples were collected before study drug administration using the nebulizer method and sent to a central laboratory for analysis. An average was taken over all post-baseline samples collected no later than one day after the last dose of study drug. | The analysis population included all randomized participants who received at least one dose of study drug and had sputum absolute neutrophil counts at Baseline or Week 4 | Posted | Mean | Standard Deviation | Neutrophil count X10^9/L | Baseline and while on study drug (up to 4 weeks) |
|
|
|
| Secondary | Mean Change From Baseline in Total Asthma Symptom Score | Total Asthma Symptom Score is the sum of individual symptoms of wheezing, coughing, and dyspnea assessed twice daily (morning and evening) and is recorded on a comment diary card. Each of the symptoms receives a daily score from 0 (none) to 3 (severe), averaged over the two daily assessments. The total score ranges from 0 to 9, with a lower score indicating less severe asthma symptoms. | The analysis population included all randomized participants who received at least one dose of study drug and had Asthma Symptom Scores evaluated at the time points reported | Posted | Mean | Standard Deviation | Score on a scale | Baseline and Weeks 1, 2, 3, and 4 |
|
|
|
| Secondary | Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second (FEV1) | Spirometry was used to measure post-bronchodilator FEV1 at Baseline and before study drug administration at Weeks 1, 2, 3, and 4. Participants received 4 puffs of bronchodilator (salbutamol hydrofluoroalkane or equivalent) at 30-second intervals and spirometry was performed 30 minutes later. The mean change from baseline is based on the average change over all post-baseline assessments. | The analysis population included all randomized participants who received at least one dose of study drug and had endpoint assessment at Baseline or at any post-baseline visit | Posted | Mean | Standard Deviation | Liters | Baseline and up to 4 weeks |
|
|
|
| Secondary | Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) | The AQLQ[S] was administered at Baseline and at Weeks 2 and 4. The assessment consists of a 32-item questionnaire covering 4 domains: symptoms, emotional functioning, impact of environmental stimuli, and activity limitation. Each item receives a score from 1 (worst, or most affected) to 7 (not at all affected). The score is the mean across all items, and ranges from 1 to 7. The mean change from baseline is based on the average change over all post-baseline assessments. | The analysis population included all randomized participants who received at least one dose of study drug and had endpoint evaluation at Baseline or at any post-baseline visit | Posted | Mean | Standard Deviation | Score on a scale | Baseline and up to 4 weeks |
|
|
|
| Secondary | Number of Participants With an Adverse Event (AE) | An AE is any untoward medical occurrence in a participant administered study drug 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 analysis population included all participants who received at least one dose of study drug | Posted | Number | Participants | Up to 5 weeks |
|
|
|
| Secondary | Number of Participants With an Electrocardiogram Adverse Event | The endpoint measured was any electrocardiogram abnormality that was reported as an AE. An AE is any untoward medical occurrence in a participant administered study drug 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 analysis population included all participants who received at least one dose of study drug | Posted | Number | Participants | Week 4 |
|
|
|
| Secondary | Number of Participants With a Laboratory Adverse Event | The endpoint measured was any laboratory (hematology, blood chemistry, or urinalysis) abnormality that was reported as an AE. An AE is any untoward medical occurrence in a participant administered study drug 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 analysis population included all participants who received at least one dose of study drug | Posted | Number | Participants | Up to 5 weeks |
|
|
|
| Secondary | Number of Participants Who Discontinued the Study Because of an Adverse Event | An AE is any untoward medical occurrence in a participant administered study drug 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 analysis population included all participants who received at least one dose of study drug | Posted | Number | Participants | Up to 5 weeks |
|
|
|
| Secondary | Number of Participants Who Discontinued Treatment Because of an Adverse Event or a Protocol-defined Clinical Event | An AE is any untoward medical occurrence in a participant administered study drug 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. A protocol-defined clinical event is an asthma exacerbation requiring addition of or increase in systemic steroids, as determined by the investigator. | The analysis population included all participants who received at least one dose of study drug | Posted | Number | Participants | Up to 4 weeks |
|
|
|
| Secondary | Maximum Plasma Concentration of Navarixin (Cmax) | Plasma samples were to be collected at baseline and up to 24 hours after dosing with navarixin at Weeks 1, 2, 3, and 4 | The analysis population was to include all participants who received at least one dose of navarixin and had navarixin plasma concentrations available for endpoint evaluation. The planned outcome measure was not evaluated. | Posted | Week 1, 2, 3, and 4 |
|
|
| 0 |
| 22 |
| 11 |
| 22 |
| EG001 | Placebo | Placebo capsule to be taken by mouth once daily for 4 weeks | 0 | 12 | 8 | 12 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Bacterial infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Furuncle | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation.
| Change at 2 weeks (n=20, 12) |
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| Change at 3 weeks (n=19, 12) |
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| Change at 4 weeks (n=18, 9) |
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