NCT00632502CompletedPhase 2
Safety of SCH 527123 in Subjects With Neutrophilic Asthma
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 37
- Primary Endpoint
- Number of Participants Who Maintained an Absolute Peripheral Blood Neutrophil Count >=1500/µL
Study Overview
Brief Summary
4-Week Safety Study in Subjects with Neutrophilic Asthma
Detailed Description
Effect of treatment with navarixin (MK-7123, SCH 527123) on sputum neutrophils and asthma symptoms
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 to <=70 years of age, either sex, any race.
- •Induced sputum neutrophil count >=40% of total white blood cells and <10 million/mL at Screening.
- •Documented diagnosis of asthma (within past 5 years), determined by at least one of the following: >=12% and 200 mL improvement in Forced Expiratory Volume in 1 second (FEV1) post-bronchodilator, and/or airway hyperresponsiveness (eg, positive methacholine challenge <8 mg/mL).
- •Nonsmoker or previous smoker with cumulative smoking history less than 20 pack-years (pack-year = 20 cigarettes smoked daily for 1 year). Previous smokers may not have smoked within 1 year prior to Screening.
- •Must not have had an exacerbation of asthma for 4 weeks prior to Screening and must be on a stable medication regimen for asthma at least 4 weeks prior to Screening.
- •Must be receiving >=800 mcg/day of beclomethasone dipropionate (BDP) or equivalent for at least 3 months prior to Screening (and on stable dose for at least 4 weeks prior to Screening).
- •Must be willing to give written informed consent to participate in the study
- •Must be capable of complying with the dosing regimen, adhere to the visit schedule, and participate in all treatment procedures, including sputum induction.
- •Female subject of childbearing potential must have a negative serum pregnancy test at Screening and must be using a medically acceptable, highly effective, adequate form of birth control (ie, failure rate <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 subject 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. A female subject should be encouraged to continue using a highly effective method of birth control for 30 days following the end of treatment.
- •Male subject must agree to use an adequate form of contraception for the duration of the study and agree to have sexual relations only with women who use a highly effective birth control method.
Exclusion Criteria
- •Chronic Obstructive Pulmonary Disease (COPD)/other relevant lung disease (other than asthma).
- •4 weeks prior to/or Screening: upper/lower respiratory tract infection.
- •Prohibited medications received more recently than indicated washout prior to Screening
- •Screening: Inadequate amount or difficulty producing sputum.
- •Screening: Sputum neutrophil count over 10 million/mL.
- •Screening: peripheral blood neutrophil (PBN) count <3000/µL.
- •Post-bronchodilator FEV1 <1L.
- •Clinically significant chronic infectious disease(s) (eg, Human Immunodeficiency Virus [HIV], hepatitis B or C).
- •Allergy/sensitivity to study drug/excipients.
- •Breast-feeding, pregnant/intends to become pregnant during study.
- •Requiring mechanical ventilation for respiratory event within 6 months of Screening.
- •Medical condition(s) (eg, hematologic, cardiovascular, renal, hepatic, neurologic, or metabolic) or medication that may interfere with effect of study medication.
- •Within 30 days of Screening: any other investigational drug.
- •Participation in any other clinical study.
- •Part of the staff personnel involved with the study.
- •Family member of investigational study staff.
Arms & Interventions
Navarixin
Experimental
Navarixin (MK-7123, SCH 527123) 30 mg capsule, to be taken by mouth once daily in the morning for 4 weeks
Intervention: Navarixin (Drug)
Navarixin
Experimental
Navarixin (MK-7123, SCH 527123) 30 mg capsule, to be taken by mouth once daily in the morning for 4 weeks
Intervention: Rescue medication (Drug)
Placebo
Placebo Comparator
Placebo capsule to match navarixin, to be taken by mouth once daily in the morning for 4 weeks
Intervention: Placebo (Drug)
Placebo
Placebo Comparator
Placebo capsule to match navarixin, to be taken by mouth once daily in the morning for 4 weeks
Intervention: Rescue medication (Drug)
Outcomes
Primary Outcomes
Number of Participants Who Maintained an Absolute Peripheral Blood Neutrophil Count >=1500/µL
Time Frame: Up to 4 weeks
Peripheral blood neutrophil counts were performed on Day 2 and Weeks 1, 2, 3, and 4 of the treatment period
Secondary Outcomes
- Mean Change From Baseline in Sputum Absolute Neutrophil Count(Baseline and while on study drug (up to 4 weeks))
- Mean Change From Baseline in Total Asthma Symptom Score(Baseline and Weeks 1, 2, 3, and 4)
- Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second (FEV1)(Baseline and up to 4 weeks)
- Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S])(Baseline and up to 4 weeks)
- Number of Participants With an Adverse Event (AE)(Up to 5 weeks)
- Number of Participants With an Electrocardiogram Adverse Event(Week 4)
- Number of Participants With a Laboratory Adverse Event(Up to 5 weeks)
- Number of Participants Who Discontinued the Study Because of an Adverse Event(Up to 5 weeks)
- Number of Participants Who Discontinued Treatment Because of an Adverse Event or a Protocol-defined Clinical Event(Up to 4 weeks)
- Maximum Plasma Concentration of Navarixin (Cmax)(Week 1, 2, 3, and 4)
Investigators
Similar Trials
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Not Applicable
Safety of SCH 527123 in Subjects with Neutrophilic AsthmaEUCTR2007-005615-26-GRSchering-Plough Research Institute, a Division of Schering Corporation30
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Safety of SCH 527123 in Subjects with Neutrophilic Asthmaeutrophilic AsthmaMedDRA version: 9.1Level: LLTClassification code 10003553Term: AsthmaEUCTR2007-005615-26-DESchering-Plough Research Institute, a Division of Schering Corporation30
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Safety of SCH 527123 in Subjects With Neutrophilic Asthma - NDEUCTR2007-005615-26-ITSchering Plough Research Institute, a division of Schering Corporation30