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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 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

176

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: MN-221
Dose: intravenous 1-hour infusion of MN-221 (total dose 1200 μg) or matching placebo.
Andere namen:
  • bedoradrine sulfate
Placebo-vergelijker: 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.
Geneesmiddel: Placebo

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
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.
Tijdsspanne: Hour 3
Hour 3

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

MediciNova

Onderzoekers

  • Studie directeur: Kazuko Matsuda, MD, MediciNova

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 maart 2009

Primaire voltooiing (Werkelijk)

1 maart 2012

Studie voltooiing (Werkelijk)

1 maart 2012

Studieregistratiedata

Eerst ingediend

5 februari 2009

Eerst ingediend dat voldeed aan de QC-criteria

5 februari 2009

Eerst geplaatst (Schatting)

6 februari 2009

Updates van studierecords

Laatste update geplaatst (Schatting)

5 september 2013

Laatste update ingediend die voldeed aan QC-criteria

4 september 2013

Laatst geverifieerd

1 september 2013

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • MN-221-CL-007

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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