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Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema (EMPHASIS)

3. März 2017 aktualisiert von: Otsuka Pharmaceutical Development & Commercialization, Inc.

A Multi-center, Randomized, Double-blind, Placebo-controlled Pilot Study to Assess the Pharmacodynamics, Efficacy and Safety of 50 mg Tetomilast Administered as Oral Tablets in Patients With Chronic Obstructive Pulmonary Disease Associated With Emphysema THIS STUDY IS CLOSED TO ENROLLMENT AND NEW SITES

Phase 2a multicenter, randomized, double-blind, placebo-controlled study to assess the pharmacodynamics, efficacy, and safety of tetomilast in patients with emphysema.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

84

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten, 35294
        • UAB Lung Health Center
    • California
      • Torrance, California, Vereinigte Staaten, 90502
        • Los Angeles Biomedical Institute
    • Florida
      • Kissimmee, Florida, Vereinigte Staaten, 34741
        • Pulmonary Disease Specialist/PDS Research
      • Miami, Florida, Vereinigte Staaten, 33143
        • Well Pharma Medical Research
      • Winter Park, Florida, Vereinigte Staaten, 32789
        • Florida Premier Research Institute
    • Georgia
      • Austell, Georgia, Vereinigte Staaten, 30106
        • Georgia Clinical Research
    • Illinois
      • Peoria, Illinois, Vereinigte Staaten, 61606
        • Illinios Lung Institute
    • Kentucky
      • Louisville, Kentucky, Vereinigte Staaten, 40202
        • University of Louisville, Pulmonary Division
    • Nebraska
      • Omaha, Nebraska, Vereinigte Staaten, 68198
        • University of Nebraska Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19140
        • Temple University Hospital
    • South Carolina
      • Spartanburg, South Carolina, Vereinigte Staaten, 29303
        • Spartanburg Medical Research
    • Texas
      • Houston, Texas, Vereinigte Staaten, 77034
        • Texas Institute of Chest and Sleep Disorders, PA
      • San Antonio, Texas, Vereinigte Staaten, 78229
        • Diagnostics Research Group
    • Virginia
      • Richmond, Virginia, Vereinigte Staaten, 23225
        • Pulmonary Associates of Richmond
    • Washington
      • Tacoma, Washington, Vereinigte Staaten, 98405
        • Multicare Pulmonary Specialist

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

40 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Male or female, 40-75 yrs old,inclusive.
  • Rating of greater than or equal to 1 on the Goddard scale in assessment of emphysema severity by HRCT.
  • FEV1: FVC greater than 70% predicted.
  • At least 1 documented COPD exacerbation within the past year but not within 8 weeks of randomization.
  • Current or former smokers with a cigarette smoking history of at least 20 pack-years (or equivalent) and whose smoking status has not changed 60 days prior to screening.

Exclusion Criteria:

  • Patients with asthma, active tuberculosis or bronchiectasis.
  • A respiratory tract infection within 30 days prior to the screening visit.
  • Any malignancy within the last 5 years with the exception of non-melanomatous skin cancer.
  • Uncontrolled cardiovascular, endocrine, blood, or nervous system disorders.
  • Uncontrolled condition with COPD exacerbation of level 2 or 3 in the 8-week period prior to randomization.
  • Systemic use of corticosteroids or other immunosuppressive agents within 30 days of the screening visit.
  • Subjects taking anticoagulants.

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
Placebo-Komparator: 2 Placebo
Arzneimittel: placebo
Placebo for 104 weeks (2 years)
Experimental: 1 Tetomilast
Arzneimittel: tetomilast
Oral tetomilast 25 mg once daily for 2 weeks followed by 50 mg once daily for 2 years.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline to Week 104 in Trough Forced Expiratory Volume in 1 Second (FEV1)
Zeitfenster: Baseline to Week 104
The analysis of the change from Baseline to Week 104 (last observation carried forward [LOCF]) in trough FEV1 is presented below.
Baseline to Week 104
Rate of Change From Baseline to Week 104 in 20th Percentile of Lung Density Voxels
Zeitfenster: Baseline to Week 104
The analysis of the change from Baseline to Week 104 (LOCF) in the 20th percentile of lung density voxels (expressed in Hounsfield unit [HU] using quantitative HCRT) by visit and lung region is presented below.
Baseline to Week 104

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percent Change From Baseline in Trough FEV1 From Baseline to Week 104
Zeitfenster: Baseline to Week 104
The percent change for the pulmonary function tests (PFT) from baseline was calculated for each study week as follows: % change from baseline = ([value at Week X - value at baseline] /value at baseline) x 100.
Baseline to Week 104
Density Mask Score Based on Specified Thresholds Including -950 HU
Zeitfenster: Baseline and Week 104
The density mask score is defined as the percentage of lung density voxels that lie below a specified threshold in the lung region of interest. The higher the percentage of the participant's lung density voxels that lie below a specified threshold, the higher the level of the participant's emphysema in the lung region under consideration. Changes in the density mask score was assessed using only a single density mask threshold of -950 HU.
Baseline and Week 104
Rate of Change in the 20th Percentile of Lung Density Voxels Expressed in HU Units for the Whole Lung (Whole Right + Whole Left) From Baseline to Week 104
Zeitfenster: Baseline to Week 104
The rate of change in lung density was calculated as the change in the 20th percentile of lung density voxels divided by the duration between the dates of measurement (month or year) where applicable. For example, if HRCT measurements are available over a span of 2 years, the annual rate of change was calculated as the difference over the 2 years divided by 2, where years between scans is given by years= floor(data of last scan - date of first scan + 1)/365.25.
Baseline to Week 104
Observed Rate of Change in Emphysema From Baseline to Week 104
Zeitfenster: Baseline to Week 104
The level of emphysema (g/L) within in a lung region is defined as the value of the selected percentile (10th, 15th, or 20th) in HU + 1000. The rate of change in the emphysema from baseline was calculated as the change in the level of emphysema from baseline to the specified visit divided by the time in years between the baseline and specified visit (i.e., [date of visit - date of baseline visit + 1]/365.25).
Baseline to Week 104
Change From Baseline to Week 104 in Cumulative Frequency of HU
Zeitfenster: Baseline and Week 104
The area under the curve (AUC) is defined as the cumulative voxel frequency in HU (ie, the value of the density mask denominator). Blood samples (4 mL) for pharmacokinetic analysis were collected for the determination of plasma OPC-6535 concentrations at Predose on Day 1 and Weeks 26, 52, 78 and 104.
Baseline and Week 104
Change From Baseline to Week 104 in Computed Tomography (CT) - Derived Lung Volumes (Total Lung Capacity [TLC] and Residual Volume [RV])
Zeitfenster: Baseline to Week 104
Change from baseline in CT-derived lung volumes TLC and RV are presented in the below outcome data table.
Baseline to Week 104
Change From Baseline to Week 104 in Trough RV/TLC
Zeitfenster: Baseline to Week 104
Change from Baseline in Trough RV/TLC is presented in the below outcome data table.
Baseline to Week 104
Change From Baseline to Week 104 in Trough Inspiratory Capacity
Zeitfenster: Baseline toWeek 104
Change from Baseline in Trough Inspiratory Capacity is presented in the below outcome data table.
Baseline toWeek 104
Change From Baseline to Week 104 in Trough Functional Residual Capacity (FRCpleth)
Zeitfenster: Baseline to Week 104
Change from baseline in trough FRCpleth is presented in the below outcome data table.
Baseline to Week 104
Change From Baseline to Week 104 in Carbon Monoxide Diffusion Capacity (DLco)
Zeitfenster: Baseline to Week 104
Change from Baseline in DLco is presented in the below outcome data table.
Baseline to Week 104
Change From Baseline to Week 104 in Mean Specific Airway Resistance (sRaw) and Specific Conductance (sGaw)
Zeitfenster: Baseline to Week 104
Change from baseline in sRaw and sGaw is presented in the below outcome data table.
Baseline to Week 104
Change From Baseline to Week 104 in 7-day Average Total Symptom Score of Dyspnea, Cough and Sputum
Zeitfenster: Baseline to Week 104
Participants used the Breathlessness, Cough, and Sputum Scale (BCSS) as the diary to daily monitor and rate their symptoms of difficulty breathing, cough, and sputum. The scale allows patients to rate each symptom on a scale of 0 (no difficultly for breathing and sputum, or unaware of coughing) to 4 (an almost constant problem for breathing and sputum, or almost constant for cough).
Baseline to Week 104
Change From Baseline to Week 104 in 7-day Mean Number of Actuations of Rescue Medications
Zeitfenster: Baseline to Week 104
Participants recorded rescue medication use (albuterol and/or ipratropium bromide) in a rescue medication log.
Baseline to Week 104
Percentage of Participants With COPD Exacerbations by Group at Week 104
Zeitfenster: Baseline and Week 104
For the COPD exacerbations, baseline is defined as Randomization (Day 1). COPD exacerbations, defined as an acute worsening of COPD symptoms, were classified as being in one of 3 levels: Level I (can by self-managed by the participant); Level II (requires a physician visit), or Level III (requires a hospital visit).
Baseline and Week 104
Percentage of Participants Experiencing a COPD Exacerbation (Level 2 or Higher)
Zeitfenster: Baseline and Week 104
Percentage of participants experiencing a COPD exacerbation in a level 2 or higher are presented in the below outcome data table.
Baseline and Week 104

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

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

1. März 2009

Primärer Abschluss (Tatsächlich)

1. Juli 2015

Studienabschluss (Tatsächlich)

1. August 2015

Studienanmeldedaten

Zuerst eingereicht

31. März 2009

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. April 2009

Zuerst gepostet (Schätzen)

2. April 2009

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. April 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. März 2017

Zuletzt verifiziert

1. März 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 197-08-250

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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