Neutrophilic Asthma Study With Navarixin (MK-7123, SCH 527123) (MK-7123-017)(COMPLETED)

NCT ID: NCT00632502

Last Updated: 2019-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-01
• Study Completion Date: 2009-02-01

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

Conditions

Neutrophilic Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Navarixin

Navarixin (MK-7123, SCH 527123) 30 mg capsule, to be taken by mouth once daily in the morning for 4 weeks

Group Type: EXPERIMENTAL

Navarixin

Intervention Type: DRUG

Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 4 weeks.

Rescue medication

Intervention Type: DRUG

Participant choice of short-acting beta-2 agonist (salbutamol/albuterol), anticholinergic, or combination medication as needed for asthma symptoms

Placebo

Placebo capsule to match navarixin, to be taken by mouth once daily in the morning for 4 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo capsule to match navarixin to be taken by mouth once daily in the morning for 4 weeks.

Rescue medication

Intervention Type: DRUG

Participant choice of short-acting beta-2 agonist (salbutamol/albuterol), anticholinergic, or combination medication as needed for asthma symptoms

Interventions

Navarixin

Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 4 weeks.

Intervention Type: DRUG

Placebo

Placebo capsule to match navarixin to be taken by mouth once daily in the morning for 4 weeks.

Intervention Type: DRUG

Rescue medication

Participant choice of short-acting beta-2 agonist (salbutamol/albuterol), anticholinergic, or combination medication as needed for asthma symptoms

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: RESULT

PMID: 22702508 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

2007-005615-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P05365

Identifier Type: OTHER

Identifier Source: secondary_id

P05365

Identifier Type: -

Identifier Source: org_study_id