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

10. desember 2018 oppdatert av: Merck Sharp & Dohme LLC

Safety of SCH 527123 in Subjects With Neutrophilic Asthma

4-Week Safety Study in Subjects with Neutrophilic Asthma

Studieoversikt

Detaljert beskrivelse

Effect of treatment with navarixin (MK-7123, SCH 527123) on sputum neutrophils and asthma symptoms

Studietype

Intervensjonell

Registrering (Faktiske)

37

Fase

  • Fase 2

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Navarixin
Navarixin (MK-7123, SCH 527123) 30 mg capsule, to be taken by mouth once daily in the morning for 4 weeks
Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 4 weeks.
Participant choice of short-acting beta-2 agonist (salbutamol/albuterol), anticholinergic, or combination medication as needed for asthma symptoms
Placebo komparator: Placebo
Placebo capsule to match navarixin, to be taken by mouth once daily in the morning for 4 weeks
Participant choice of short-acting beta-2 agonist (salbutamol/albuterol), anticholinergic, or combination medication as needed for asthma symptoms
Placebo capsule to match navarixin to be taken by mouth once daily in the morning for 4 weeks.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants Who Maintained an Absolute Peripheral Blood Neutrophil Count >=1500/µL
Tidsramme: Up to 4 weeks
Peripheral blood neutrophil counts were performed on Day 2 and Weeks 1, 2, 3, and 4 of the treatment period
Up to 4 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean Change From Baseline in Sputum Absolute Neutrophil Count
Tidsramme: Baseline and while on study drug (up to 4 weeks)
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.
Baseline and while on study drug (up to 4 weeks)
Mean Change From Baseline in Total Asthma Symptom Score
Tidsramme: Baseline and Weeks 1, 2, 3, and 4
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)
Tidsramme: Baseline and up to 4 weeks
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])
Tidsramme: Baseline and up to 4 weeks
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)
Tidsramme: Up to 5 weeks
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
Tidsramme: Week 4
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
Tidsramme: Up to 5 weeks
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
Tidsramme: Up to 5 weeks
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
Tidsramme: Up to 4 weeks
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)
Tidsramme: Week 1, 2, 3, and 4
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2008

Primær fullføring (Faktiske)

1. februar 2009

Studiet fullført (Faktiske)

1. februar 2009

Datoer for studieregistrering

Først innsendt

29. februar 2008

Først innsendt som oppfylte QC-kriteriene

29. februar 2008

Først lagt ut (Anslag)

10. mars 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. januar 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. desember 2018

Sist bekreftet

1. desember 2018

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • P05365 (Annen identifikator: Merck protocol number)
  • 2007-005615-26 (EudraCT-nummer)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Studiedata/dokumenter

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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