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

10 de diciembre de 2018 actualizado por: Merck Sharp & Dohme LLC

Safety of SCH 527123 in Subjects With Neutrophilic Asthma

4-Week Safety Study in Subjects with Neutrophilic Asthma

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

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

Tipo de estudio

Intervencionista

Inscripción (Actual)

37

Fase

  • Fase 2

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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
Comparador de placebos: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants Who Maintained an Absolute Peripheral Blood Neutrophil Count >=1500/µL
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean Change From Baseline in Sputum Absolute Neutrophil Count
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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])
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de mayo de 2008

Finalización primaria (Actual)

1 de febrero de 2009

Finalización del estudio (Actual)

1 de febrero de 2009

Fechas de registro del estudio

Enviado por primera vez

29 de febrero de 2008

Primero enviado que cumplió con los criterios de control de calidad

29 de febrero de 2008

Publicado por primera vez (Estimar)

10 de marzo de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de enero de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

10 de diciembre de 2018

Última verificación

1 de diciembre de 2018

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • P05365 (Otro identificador: Merck protocol number)
  • 2007-005615-26 (Número EudraCT)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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

Datos del estudio/Documentos

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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