- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00632502
Neutrophilic Asthma Study With Navarixin (MK-7123, SCH 527123) (MK-7123-017)(COMPLETED)
10. Dezember 2018 aktualisiert von: Merck Sharp & Dohme LLC
Safety of SCH 527123 in Subjects With Neutrophilic Asthma
4-Week Safety Study in Subjects with Neutrophilic Asthma
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Effect of treatment with navarixin (MK-7123, SCH 527123) on sputum neutrophils and asthma symptoms
Studientyp
Interventionell
Einschreibung (Tatsächlich)
37
Phase
- Phase 2
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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
|
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of Participants Who Maintained an Absolute Peripheral Blood Neutrophil Count >=1500/µL
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Mean Change From Baseline in Sputum Absolute Neutrophil Count
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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])
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Mai 2008
Primärer Abschluss (Tatsächlich)
1. Februar 2009
Studienabschluss (Tatsächlich)
1. Februar 2009
Studienanmeldedaten
Zuerst eingereicht
29. Februar 2008
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
29. Februar 2008
Zuerst gepostet (Schätzen)
10. März 2008
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
2. Januar 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
10. Dezember 2018
Zuletzt verifiziert
1. Dezember 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- P05365 (Andere Kennung: Merck protocol number)
- 2007-005615-26 (EudraCT-Nummer)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Studiendaten/Dokumente
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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