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Phase 2 Completed N=37 Randomized Triple-blind Treatment

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

Neutrophilic Asthma
Source: ClinicalTrials.gov NCT00632502 ↗
Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcomePrimary: Number of Participants Who Maintained an Absolute Peripheral Blood Neutrophil Count >=1500/µL — 20; 12 Number of participants

Summary

4-Week Safety Study in Subjects with Neutrophilic Asthma

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Who Maintained an Absolute Peripheral Blood Neutrophil Count >=1500/µL
20; 12
SECONDARY
Mean Change From Baseline in Sputum Absolute Neutrophil Count
3.275; 3.408; -0.270; 0.680
SECONDARY
Mean Change From Baseline in Total Asthma Symptom Score
2.47; 2.40; -0.07; 0.05; -0.25; 0.19
SECONDARY
Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second (FEV1)
2.197; 1.851; -0.099; -0.094
SECONDARY
Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S])
4.822; 4.897; 0.165; 0.119
SECONDARY
Number of Participants With an Adverse Event (AE)
13; 8
SECONDARY
Number of Participants With an Electrocardiogram Adverse Event
0; 0
SECONDARY
Number of Participants With a Laboratory Adverse Event
2; 0
SECONDARY
Number of Participants Who Discontinued the Study Because of an Adverse Event
0; 1
SECONDARY
Number of Participants Who Discontinued Treatment Because of an Adverse Event or a Protocol-defined Clinical Event
2; 2; 1; 1
SECONDARY
Maximum Plasma Concentration of Navarixin (Cmax)

Eligibility Criteria

Inclusion Criteria

  • 18 to =40% of total white blood cells and =12% and 200 mL improvement in Forced Expiratory Volume in 1 second (FEV1) post-bronchodilator, and/or airway hyperresponsiveness (eg, positive methacholine challenge =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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00632502). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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