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Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo (LAC-MD-27)

16. januar 2017 opdateret af: AstraZeneca

Efficacy and Safety Study of Two Fixed-Dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate, and Placebo All Administered Twice Daily (BID) to Patients With Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to evaluate the efficacy of this multicenter, randomized, double-blind, placebo-controlled, 4-period, incomplete-block crossover, dose-ranging study comparing 2 fixed dose combinations (FDCs) of aclidinium bromide with formoterol fumarate or with placebo, aclidinium bromide and formoterol fumarate, all administered twice a day (BID) in patients with stable, moderate to severe chronic obstructive pulmonary disease (COPD) beginning with a 2-week run-in period and with a 7-10 day washout each between treatment period.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

128

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
    • Arizona
      • Glendale, Arizona, Forenede Stater, 85306
        • Forest Investigative Site 0909
      • Pheonix, Arizona, Forenede Stater, 85006
        • Forest Investigative Site 2050
    • California
      • Rancho Mirage, California, Forenede Stater, 92270
        • Forest Investigative Site 2029
      • Stockton, California, Forenede Stater, 95207
        • Forest Investigative Site 1084
    • Colorado
      • Wheat Ridge, Colorado, Forenede Stater, 80033
        • Forest Investigative Site 2045
    • Florida
      • Clearwater, Florida, Forenede Stater, 33765
        • Forest Investigative Site 1152
      • Tampa, Florida, Forenede Stater, 33603
        • Forest Investigative Site 2053
      • Tampa, Florida, Forenede Stater, 33613
        • Forest Investigative Site 2047
    • Massachusetts
      • N. Dartmouth, Massachusetts, Forenede Stater, 02747
        • Forest Investigative Site 1431
    • New Jersey
      • Summit, New Jersey, Forenede Stater, 07901
        • Forest Investigative Site 2084
    • New York
      • Elmira, New York, Forenede Stater, 14901
        • Forest Investigative Site 1119
    • North Carolina
      • Elizabeth city, North Carolina, Forenede Stater, 27909
        • Forest Investigative Site 2035
      • Raleigh, North Carolina, Forenede Stater, 27607
        • Forest Investigative Site 1153
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45242
        • Forest Investigative Site 2028
    • Oregon
      • Medford, Oregon, Forenede Stater, 97504
        • Forest Investigative Site 2043
      • Portland, Oregon, Forenede Stater, 97213
        • Forest Investigative Site 1106
    • Rhode Island
      • E. Providence, Rhode Island, Forenede Stater, 02914
        • Forest Investigative Site 1089
    • South Carolina
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • Forest Investigative Site 1121
    • Texas
      • San Antonio, Texas, Forenede Stater, 78215
        • Forest Investigative Site 1498
      • Waco, Texas, Forenede Stater, 76712
        • Forest Investigative Site 1129

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 til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Understand the study procedures and be willing to participate in the study as indicated by signing the ICF and HIPAA form
  • Be male or female aged 40 to 80 years, inclusive
  • Have a diagnosis of stable, moderate to severe COPD (stages II and III) as defined by guidelines of the Global Initiative for Chronic Obstructive Lung Disease (2008)
  • Be a current or former cigarette smoker with a smoking history of at least 10 pack-years
  • Have post-albuterol/salbutamol FEV1 values ≥ 30% and < 80% of the predicted value. FEV1 will be measured at the Screening Visit (Visit 1) between 10 and 15 minutes after inhalation of albuterol/salbutamol.
  • Have post-albuterol/salbutamol FEV1/FVC values < 70% (ie, 100 × post- albuterol/salbutamol FEV1/FVC < 70%).
  • If female, be at least 1 year postmenopausal or surgically sterile (defined as having a hysterectomy or tubal ligation). Women of childbearing potential must have a negative serum β-human chorionic gonadotropin pregnancy test at screening
  • Be in good stable health (as judged by the Investigator) other than the COPD, based on medical history, physical examination, ECG, spirometry, and clinical laboratory data evaluations
  • Have COPD symptoms and FEV1 values at the time of randomization that are stable compared with those at Screening (Visit 1), according to the Investigator's medical judgment

Exclusion Criteria:

  • Have been hospitalized for an acute COPD exacerbation within 3 months before screening
  • Have any respiratory tract infection (including the upper respiratory tract) or signs of a COPD exacerbation or respiratory infection in the 6 weeks before Screening (Visit 1).
  • Have any clinically significant respiratory conditions other than COPD
  • Have a history or presence of asthma verified from medical records
  • Have used theophylline (including long-acting theophylline) within the previous 3 months before study entry
  • Have Stage II hypertension, defined as systolic pressure of 160 and above, and diastolic pressure of 100 and above
  • Chronic use of oxygen therapy ≥ 15 hours a day
  • Have a history, current diagnosis, or presence of exercise-induced bronchospasm
  • Have a body mass index ≥ 40 kg/m2
  • Have participated in an pulmonary rehabilitation program within the previous 3 months
  • Have clinically significant cardiovascular conditions
  • Have uncontrolled infection resulting from human immunodeficiency virus and/or active hepatitis
  • Have symptomatic prostatic hypertrophy and/or bladder neck obstruction.
  • Have narrow-angle glaucoma
  • Have a history of hypersensitivity reaction (including report of paradoxical bronchospasm) to inhaled anticholinergics (including aclidinium bromide), β2 adrenergic agonists, or any other inhaled medication or any component thereof
  • Have a QTcB, as indicated in the centralized reading report, above 470 msec in the resting ECGs performed at Screening (Visit 1) and/or patients who are using medications that may prolong the QT interval
  • Have clinically relevant abnormalities in the results of clinical laboratory tests, in ECG parameters other than QTc, in results of the physical examination,
  • Have any concurrent medical condition that, in the judgment of the Investigator, might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient's well-being
  • Do not maintain regular day/night, waking/sleeping cycles (eg, patients with history of sleep apnea syndrome or any disease related with sleep disturbances such as restless legs syndrome or somnambulism)

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: Crossover opgave
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Aclidinium 400 μg / Formoterol 12 μg
Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)
Medicin: Aclidinium 400 μg / Formoterol 12 μg
Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods.
Eksperimentel: Aclidinium 400 μg / formoterol 6 μg
Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)
Medicin: Aclidinium 400 μg / Formoterol 6 μg
Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods.
Eksperimentel: Aclidinium 400 μg
Aclidinium bromide 400 μg administered twice-daily (BID)
Medicin: Aclidinium 400 μg
Aclidinium bromide 400 μg administered twice-daily (BID) for a 14 day period within four different treatment periods.
Aktiv komparator: Formoterol 12 μg
Formoterol fumarate 12 μg twice-daily
Medicin: Formoterol 12 μg
Formoterol fumarate 12 μg twice-daily for a 14 day period within four different treatment periods.
Placebo komparator: Placebo
Placebo twice-daily
Medicin: Placebo
Placebo twice-daily delivered by inhalation for a 14 day period within four different treatment periods.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12)
Tidsramme: 0 to 12 hours post-dose on Day 14
0 to 12 hours post-dose on Day 14

Sekundære resultatmål

Resultatmål
Tidsramme
Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)
Tidsramme: Day 14
Day 14
Change From Baseline in Morning Peak Forced Expiratory Volume in One Second (FEV1)
Tidsramme: Day 14
Day 14

Samarbejdspartnere og efterforskere

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

Sponsor

AstraZeneca

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.

Hjælpsomme links

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. december 2009

Primær færdiggørelse (Faktiske)

1. august 2010

Studieafslutning (Faktiske)

1. august 2010

Datoer for studieregistrering

Først indsendt

13. januar 2010

Først indsendt, der opfyldte QC-kriterier

13. januar 2010

Først opslået (Skøn)

14. januar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LAC-MD-27

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 .

Kliniske forsøg med Aclidinium 400 μg / Formoterol 12 μg

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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