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Study Evaluating the Safety and Efficacy of MN-221 as an Adjunct to Standard Therapy in Subjects Experiencing an Acute Exacerbation of Asthma

4. September 2013 aktualisiert von: MediciNova

MN-221-CL-007: A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MN-221 When Administered Intravenously as an Adjunct to Standard Therapy to Adults With an Acute Exacerbation of Asthma

The objective of this clinical study is to examine the safety and effectiveness of intravenous MN-221 compared to placebo when administered as an adjunct to standard therapy in subjects experiencing an acute exacerbation of asthma.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This is an international, randomized, double-blind, placebo-controlled, multi-center ED study. Each subject will receive MN-221 or placebo administered through a continuous intravenous infusion in addition to the standardized treatment for an acute exacerbation of asthma.

Upon presentation to the ED for assessment and treatment for an acute exacerbation of asthma the patient should receive standard of care consistent with the international guidelines (e.g., Global Initiative for Asthma [GINA] or the National Asthma Education and Prevention Program [NAEPP]) and required, in part, by this protocol prior to screening procedures being performed.

Prior to any study specific treatment or evaluation being performed a subject must have signed an IRB/EC/REB approved consent form. Once the subject has received the initial treatment regimen the subject will be assessed for response to the treatment including spirometry.If the subject meets all entry criteria the subject will be randomized to receive MN-221 or placebo. Throughout the screening process the subject will continue to receive standardized treatment consistent with the appropriate guidelines for the treatment of acute exacerbations of asthma.

Subjects enrolled in the study will receive an intravenous 1-hour infusion of MN-221 study drug or placebo. Subjects receiving MN-221 will be administered a total dose of 1200 μg.

During the study treatment period, the subject may continue to receive standardized treatment and be assessed. The study treatment period will be approximately 3 hours in length. Safety and efficacy will be monitored throughout the treatment period. PK parameters (if applicable) will be obtained from subjects at selected study sites. A blood sample for genomic evaluation will be collected during the treatment period (at participating sites) if the subject consents to the evaluation. An initial 24-hour post-randomization follow-up visit will be completed to evaluate the subject's health status as well as for safety and PK parameters (if applicable). A second follow-up contact will be completed by telephone seven days post-randomization for safety purposes and to evaluate the subject's health status.

A periodic risk/benefit evaluation will be performed by the study's Data Safety Monitoring Board.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

176

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
    • California
      • Loma Linda, California, Vereinigte Staaten, 92354
        • Loma Linda University Medical Center
      • San Diego, California, Vereinigte Staaten, 92037
        • UCSD Medical Center - Thornton Hospital
      • San Diego, California, Vereinigte Staaten, 92103
        • UCSD Medical Center
      • Sylmar, California, Vereinigte Staaten, 91342
        • Olive View - UCLA Medical Center
    • Illinois
      • Maywood, Illinois, Vereinigte Staaten, 60153
        • Loyola University Medical Center
    • Massachusetts
      • Newton, Massachusetts, Vereinigte Staaten, 02462
        • Newton - Wellesley Hospital
      • Springfield, Massachusetts, Vereinigte Staaten, 01199
        • Baystate Medical Center
    • Minnesota
      • Minneapolis, Minnesota, Vereinigte Staaten, 55415
        • Hennepin County Medical Center
    • Missouri
      • St. Louis, Missouri, Vereinigte Staaten, 63110
        • Washington University School of Medicine
    • New Jersey
      • Hackensack, New Jersey, Vereinigte Staaten, 07601
        • Hackensack University Medical Center
    • Ohio
      • Cincinnati, Ohio, Vereinigte Staaten, 45267-0563
        • University of Cincinnati
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19141
        • Albert Einstein Healthcare Network
    • Rhode Island
      • Providence, Rhode Island, Vereinigte Staaten, 02903
        • Rhode Island Hospital
    • Texas
      • Dallas, Texas, Vereinigte Staaten, 75390
        • University of Texas Southwestern Medical Center
    • Virginia
      • Norfolk, Virginia, Vereinigte Staaten, 23507
        • Sentara General Hospital

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 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Subjects meeting all of the following criteria will be considered for admission to the study:

    1. Male or female 18 to 65 years of age, inclusive;
    2. Self-reported history of physician-diagnosed and treated asthma for ≥ 3 months prior to randomization;
    3. A diagnosis of an acute exacerbation of asthma upon presentation at the ED as defined by dyspnea and evidence of bronchospasm;

    4. Received the following Standardized Treatment within a 2-hour time window and prior to obtaining the Qualifying Spirometry value(FEV1):

      • Supplemental oxygen given to maintain oxygen saturation as measured by pulse oximetry of ≥ 90% as needed;
      • Albuterol 5-15mg of albuterol via nebulizer prior to the qualifying spirometry evaluation; simultaneously with
      • Ipratropium 0.5-1.5 mg of ipratropium via nebulizer prior to the qualifying spirometry evaluation;
      • One dose of corticosteroid of at least 50 mg given orally (prednisone) or intravenously (methylprednisolone) or the equivalent dose of another corticosteroid.
    5. FEV1 of ≤ 50% of predicted; NOTE: Spirometry to measure the subject's FEV1 expressed as % of predicted within 30 minutes of completing administration of 5 mg (but not more than 15 mg) albuterol and 0.5 mg (but not more than 1.5 mg) of ipratropium..
    6. Negative urine pregnancy test for all females of child-bearing potential;
    7. ECG with no dysrhythmias (except sinus tachycardia);
    8. No clinical or electrocardiographic signs of ischemic heart disease as determined by the Investigator; and
    9. Legally effective written informed consent obtained prior to starting any mandated study procedures

Exclusion Criteria:

Subjects will be excluded if they meet any of the following criteria:

  1. Administration of a parenteral (intravenous or subcutaneous) beta agonist (e. g., albuterol, terbutaline, epinephrine) within 6 hours prior to randomization;
  2. A current or prior diagnosis or suspected diagnosis of COPD or other chronic lung disease other than asthma;
  3. Presence of pneumonia;
  4. Presence of significant other respiratory dysfunction such as pneumothorax, pneumomediastinum, or pulmonary edema;
  5. Known or suspected vocal cord dysfunction syndrome;
  6. Presence of aspirated foreign body (known or suspected);
  7. History or any current clinical evidence suggesting cardiomyopathy or congestive heart failure;
  8. History or presence of tachyarrhythmias, with the exception of sinus tachycardia;
  9. Heart rate ≥ 140 bpm;

  10. Hypokalemia, defined as subjects with serum potassium level of <2.8 mEq/L (≤2.8 mmol/L) obtained at Screening (local stat lab, blood gas analysis, or other point of care device) with the following exception:

    For the subjects using non-potassium-sparing diuretics (i.e. loop-diuretic or thiazide diuretic) without "potassium-sparing diuretics" (e.g., Triamterene or Spironolactone) OR without potassium supplementation of at least KCl 20 mEq/day whose potassium level <3.5 mEq/L (<3.5 mmol/L) at Screening.

  11. Significant cardiac, renal, hepatic, endocrine, metabolic, neurologic or other systemic disease. A significant disease will be defined as one which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study or the subject's ability to participate in the trial;
  12. Self-reported history of greater than 20 pack-yr smoking history;
  13. Fever ≥ 102.0 ºF (38.9 ºC);
  14. Uncontrolled hypertension defined as a blood pressure ≥ 170/100 mm Hg (22.7/13.3 kPa);
  15. Need for immediate intubation, mechanical ventilation, or non-invasive positive pressure ventilation as determined by the Investigator;
  16. Pregnant or lactating females;
  17. Participated in another clinical study with an investigational drug within 30 days of randomization;
  18. Positive urine drug screen for cocaine, methamphetamine or PCP unless, in the Investigator's clinical judgment, a single positive result is explained by exposure to a non-illicit drug product (i.e., is a false positive). For example, phenylpropanolamine or methylphenidate may read positive in a methamphetamine screen; dextromethorphan in a PCP screen.
  19. Any subject with a known allergy to components of the MN-221 drug product;
  20. Any subject with a known allergy to other beta agonists;
  21. Previous exposure to MN-221; or
  22. Use of theophylline, beta blockers, digoxin, MAO inhibitors, or tricyclic antidepressants within 2 weeks prior to randomization.

Use of non-potassium-sparing diuretics (i.e. Thiazide or Loop-diuretic) without potassium-sparing diuretic OR without potassium supplementation >20 mEq/day within 2 weeks prior to randomization and if serum potassium level at Screening <3.5 mEq/L (<3.5 mmol/L).

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: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 1
MN-221 given i.v. 1-hour infusion a total dose of 1200 μg (40 μg/min for 15 min [600 μg] + 13.3 μg/min for 45 min [600 μg]) as an adjunct to the standard of care for acute exacerbation of asthma.
Arzneimittel: MN-221
Dose: intravenous 1-hour infusion of MN-221 (total dose 1200 μg) or matching placebo.
Andere Namen:
  • bedoradrine sulfate
Placebo-Komparator: Placebo
Placebo (Lot #CLO-095) was packaged in identical vials containing only excipients and administered as an i.v. 1-hour infusion with a regimen as described for MN-221.
Arzneimittel: Placebo

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
The primary efficacy analysis will be based on a change in FEV1, expressed as percent of predicted, at Hour 3 when compared to FEV1, expressed as percent of predicted, at the qualifying/screening timepoint.
Zeitfenster: Hour 3
Hour 3

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Change from baseline FEV1 % of predicted (at time points other than Hour 3)
Zeitfenster: Hours 1, 2, 3, and 24
Hours 1, 2, 3, and 24
Change from baseline FEV1 (L)
Zeitfenster: Hours 1, 2, 3 and 24
Hours 1, 2, 3 and 24
Change from baseline PEFR (L/sec)
Zeitfenster: Hours 1, 2, 3 and 24
Hours 1, 2, 3 and 24
Change from baseline PEFR, expressed as percent (%) of predicted
Zeitfenster: Hours 1, 2, 3and 24
Hours 1, 2, 3and 24
Improvement in Dyspnea index scale
Zeitfenster: Hours 1, 2, 3, 24 and Day 8
Hours 1, 2, 3, 24 and Day 8
Percent of subjects with an improvement in FEV1 ≥ 200cc
Zeitfenster: Hours 1, 2, 3 and 24
Hours 1, 2, 3 and 24
Percent of subjects with an improvement in FEV1, % predicted ≥ 5%
Zeitfenster: Hours 1, 2, 3 and 24
Hours 1, 2, 3 and 24
Percent of subjects with and improvement in FEV1, % predicted ≥ 10%
Zeitfenster: Hours 1, 2, 3 and 24
Hours 1, 2, 3 and 24
Subjects Hospitalized ( within 24 hour from start of study drug infusion)
Zeitfenster: Within 24 hours from start of study drug infusion.
Within 24 hours from start of study drug infusion.
Admitted to ICU (within 24 hours from start of study drug infusion)
Zeitfenster: Within 24 hours from start of study drug infusion.
Within 24 hours from start of study drug infusion.
Number of albuterol treatments to achieve an increase in FEV1% of predicted ≥ 15%
Zeitfenster: Hours 3
Hours 3
Total dose or number of albuterol treatments in first 3 hours following commencement of randomized medication.
Zeitfenster: No specific time points
No specific time points
Time to achieve an increase of FEV1% of predicted ≥ 15%
Zeitfenster: No specific time points
No specific time points
Time to initial albuterol treatment following the commencement of randomized medication
Zeitfenster: No specific time points
No specific time points
Hospital length of stay
Zeitfenster: No specific timepoints
No specific timepoints

Mitarbeiter und Ermittler

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

Sponsor

MediciNova

Ermittler

  • Studienleiter: Kazuko Matsuda, MD, MediciNova

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.

Allgemeine Veröffentlichungen

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. März 2012

Studienabschluss (Tatsächlich)

1. März 2012

Studienanmeldedaten

Zuerst eingereicht

5. Februar 2009

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Februar 2009

Zuerst gepostet (Schätzen)

6. Februar 2009

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

5. September 2013

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. September 2013

Zuletzt verifiziert

1. September 2013

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • MN-221-CL-007

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

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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