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

NCT00632502 | Completed Phase 2 Results DMC

• 2 other identifiers: P053652007-005615-26
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

4-Week Safety Study in Subjects with Neutrophilic Asthma

Conditions

Neutrophilic Asthma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• 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

Study Arms (2)

Navarixin

EXPERIMENTAL

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

Drug: Navarixin; Drug: Rescue medication

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: Rescue medication

Interventions

Navarixin DRUG

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

Navarixin

Placebo DRUG

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

Placebo

Rescue medication DRUG

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

Navarixin; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Chronic Obstructive Pulmonary Disease (COPD)/other relevant lung disease (other than asthma).
• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 22702508 RESULT

MeSH Terms

Interventions

navarixin

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2008
• First Posted: March 10, 2008
• Study Start: May 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: January 2, 2019
• Results First Posted: November 18, 2014

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share