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A Phase 2 Study of MP-376 to Prevent Acute Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) Patients

17. januar 2018 opdateret af: Horizon Pharma USA, Inc.

Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of MP-376 Inhalation Solution Administered for 5 Days Every 28 Days to Prevent Acute Exacerbations in High Risk COPD Patients

Patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from frequent and recurrent acute exacerbations (AECB) which are associated with enormous healthcare expenditures and significant morbidity, specifically an increased risk of death, a decline in pulmonary function and a significant change in quality of life. Bacteria appear to have an important role in acute exacerbations in chronic bronchitis and COPD. Studies of acute exacerbations in COPD have shown a reduction in bacterial load with prolonged exacerbation-free interval. In addition, recent studies indicate that acquisition of a new strain of H. influenzae, M. catarrhalis, S. pneumoniae or P. aeruginosa are responsible for many of these exacerbations. Chronic inflammation and bacterial infection predispose many patients to frequent and recurrent acute exacerbations.

Mpex believes that intermittent administration of inhaled MP-376 in high risk patients will decrease the incidence of acute exacerbations by both by lowering the organism burden, and resultant inflammation, as well as pre-emptive eradication of any newly acquired bacterial strains.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study will be a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and efficacy of MP-376 inhalation solution given daily for 5 days in a 28 day treatment cycle to COPD patients.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

322

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Haleyville, Alabama, Forenede Stater, 35565
      • Hueytown, Alabama, Forenede Stater, 35023
      • Mobile, Alabama, Forenede Stater, 36608
      • Montgomery, Alabama, Forenede Stater, 36117
    • Arizona
      • Glendale, Arizona, Forenede Stater, 85306
      • Phoenix, Arizona, Forenede Stater, 85006
    • California
      • Chula Vista, California, Forenede Stater, 91911
      • Lomita, California, Forenede Stater, 90717
      • Long Beach, California, Forenede Stater, 90822
      • Mission Viejo, California, Forenede Stater, 92691
      • Oceanside, California, Forenede Stater, 92056
      • Palo Alto, California, Forenede Stater, 94304
      • Riverside, California, Forenede Stater, 92506
      • San Diego, California, Forenede Stater, 92117
      • San Jose, California, Forenede Stater, 95124
    • Colorado
      • Wheat Ridge, Colorado, Forenede Stater, 80033
    • Florida
      • Clearwater, Florida, Forenede Stater, 33765
      • DeBary, Florida, Forenede Stater, 32713
      • DeLand, Florida, Forenede Stater, 32720
      • Orlando, Florida, Forenede Stater, 32806
    • Georgia
      • Savannah, Georgia, Forenede Stater, 31406
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70115
    • Michigan
      • Taylor, Michigan, Forenede Stater, 48180
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68198
    • New York
      • Buffalo, New York, Forenede Stater, 14215
      • Ithaca, New York, Forenede Stater, 14850
    • North Carolina
      • Greenville, North Carolina, Forenede Stater, 27834
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
      • Maumee, Ohio, Forenede Stater, 43537
      • Toledo, Ohio, Forenede Stater, 43614
    • Oregon
      • Medford, Oregon, Forenede Stater, 97504
    • Rhode Island
      • Johnston, Rhode Island, Forenede Stater, 02919
    • South Carolina
      • Easley, South Carolina, Forenede Stater, 29640
      • Gaffney, South Carolina, Forenede Stater, 29340
      • Spartanburg, South Carolina, Forenede Stater, 29303
      • Union, South Carolina, Forenede Stater, 29379
    • Texas
      • San Antonio, Texas, Forenede Stater, 78212
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23225
      • Salem, Virginia, Forenede Stater, 24153

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria (selected):

  • > 40 years of age
  • History of COPD
  • Forced expiratory volume in 1 second (FEV1) </= 70% of predicted and FEV1/Forced vital capacity (FVC) </= 0.7 value at screening
  • Have at least two acute exacerbation episodes in the proceeding year
  • Clinically stable with no changes in health status within the last 30 days
  • Lifetime smoking history of at least 10 pack-years
  • Willing and able to use a daily electronic diary

Exclusion Criteria (selected):

  • Use of any systemic or inhaled antibiotics within 30 days prior to baseline
  • History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
  • Creatinine clearance < 40 mg/ml/min, AST, ALT >/= 5 x upper limit of normal (ULN) or total bilirubin >/= 3 x ULN at Screening

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Placebo inhaled twice daily via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
Medicin: Placebo
same frequency as study drug using the same method of delivery
Andre navne:
  • MP-376 color-matched placebo
Eksperimentel: MP-376 240 mg Twice Daily (BID)
MP-376 240 mg BID inhaled via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
Medicin: MP-376
MP-376 administered via inhalation for 5 consecutive days within 28-day treatment cycles for up to 12 cycles
Andre navne:
  • Aeroquin
  • Levofloxacin inhalation solution

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Exacerbation Rate
Tidsramme: From randomization to the patients final study visit (up to 12 months)
The number of acute exacerbations per patient-year of study participation, where an acute exacerbation was defined as a deterioration in respiratory symptoms that required treatment with antibiotics, corticosteroids, hospitalization or a combination of those treatments.
From randomization to the patients final study visit (up to 12 months)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Duration of Acute Exacerbation
Tidsramme: from randomization to the patient's final study visit (up to 12 months)
From the beginning of antibiotics and/or systemic corticosteroids to the end of antibiotics and/or systemic corticosteroids, whichever was longer, for treatment of the first acute exacerbation
from randomization to the patient's final study visit (up to 12 months)
Percent Change in Forced Vital Capacity (FVC)
Tidsramme: from baseline to the conclusion of the fourth 28-day treatment cycle (4 months)
The percent change in the amount of air a patient can inhale
from baseline to the conclusion of the fourth 28-day treatment cycle (4 months)
Percent Change in Forced Expiratory Volume in 1 Second (FEV1)
Tidsramme: from baseline to the conclusion of the fourth 28-day treatment cycle (4 months)
The percent change in the amount of air a patient can exhale in 1 second
from baseline to the conclusion of the fourth 28-day treatment cycle (4 months)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Horizon Pharma USA, Inc.

Efterforskere

  • Ledende efterforsker: Sanjay Sethi, M.D., University at Buffalo

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2008

Primær færdiggørelse (Faktiske)

1. januar 2010

Studieafslutning (Faktiske)

1. april 2010

Datoer for studieregistrering

Først indsendt

20. august 2008

Først indsendt, der opfyldte QC-kriterier

21. august 2008

Først opslået (Skøn)

22. august 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. januar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. januar 2018

Sidst verificeret

1. januar 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Mpex-302

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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