Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® (PINNACLE 3)

7. februar 2017 oppdatert av: Pearl Therapeutics, Inc.

A 28-Week, Multi-Center, Randomized, Double Blind, Parallel-Group, Active-Controlled Safety Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® as an Active Control

This is a multi-center, randomized, double-blind, parallel group, chronic dosing, active-controlled, 28-week safety extension study of the two pivotal 24-week safety and efficacy studies (Studies PT003006 and PT003007). This study is designed to assess the long-term safety and tolerability of Glycopyrrolate (GP) and Formoterol Fumarate (FF) combination (GFF) metered dose inhaler (MDI), GP MDI, and FF MDI in subjects with moderate to very severe COPD over a total observation period of 52 weeks. Open-label Spiriva is included as an active control. To be eligible for this study, a subject must complete participation in Study PT003006 (NCT01854645) or Study PT003007 (NCT01854658).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

892

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Australia
    • New South Wales
      • New Lambton, New South Wales, Australia
        • Pearl Investigative Site
      • Westmead, New South Wales, Australia
        • Pearl Investigative Site
    • Queensland
      • Brisbane, Queensland, Australia
        • Pearl Investigative Site
      • Cairns, Queensland, Australia
        • Pearl Investigative Site
      • Wooloongabba, Queensland, Australia
        • Pearl Investigative Site
    • South Australia
      • Adelaide, South Australia, Australia
        • Pearl Investigative Site
    • Victoria
      • Heidelberg, Victoria, Australia
        • Pearl Investigative Site
    • Western Australia
      • Nederlands, Western Australia, Australia
        • Pearl Investigative Site
      • Perth, Western Australia, Australia
        • Pearl Investigative Site
  • Forente stater
    • Alabama
      • Andalusia, Alabama, Forente stater
        • Pearl Investigative Site
      • Anniston, Alabama, Forente stater
        • Pearl Investigative Site
      • Athens, Alabama, Forente stater
        • Pearl Investigative Site
      • Birmingham, Alabama, Forente stater
        • Pearl Investigative Site
      • Jasper, Alabama, Forente stater
        • Pearl Investigative Site
    • Arizona
      • Glendale, Arizona, Forente stater
        • Pearl Investigative Site
      • Mesa, Arizona, Forente stater
        • Pearl Investigative Site
      • Phoenix, Arizona, Forente stater
        • Pearl Investigative Site
      • Scottsdale, Arizona, Forente stater
        • Pearl Investigative Site
      • Tucson, Arizona, Forente stater
        • Pearl Investigative Site
    • California
      • Anaheim, California, Forente stater
        • Pearl Investigative Site
      • Carlsbad, California, Forente stater
        • Pearl Investigative Site
      • Lakewood, California, Forente stater
        • Pearl Investigative Site
      • Los Angeles, California, Forente stater
        • Pearl Investigative Site
      • Monterey Park, California, Forente stater
        • Pearl Investigative Site
      • Pasadena, California, Forente stater
        • Pearl Investigative Site
      • Poway, California, Forente stater
        • Pearl Investigative Site
      • Sacramento, California, Forente stater
        • Pearl Investigative Site
      • San Diego, California, Forente stater
        • Pearl Investigative Site
      • Tustin, California, Forente stater
        • Pearl Investigative Site
      • Vista, California, Forente stater
        • Pearl Investigative Site
    • Colorado
      • Colorado Springs, Colorado, Forente stater
        • Pearl Investigative Site
      • Denver, Colorado, Forente stater
        • Pearl Investigative Site
      • Fort Collins, Colorado, Forente stater
        • Pearl Investigative Site
      • Wheat Ridge, Colorado, Forente stater
        • Pearl Investigative Site
    • Connecticut
      • Danbury, Connecticut, Forente stater
        • Pearl Investigative Site
      • Waterbury, Connecticut, Forente stater
        • Pearl Investigative Site
    • Florida
      • Clearwater, Florida, Forente stater
        • Pearl Investigative Site
      • Miami, Florida, Forente stater
        • Pearl Investigative Site
      • Ormond Beach, Florida, Forente stater
        • Pearl Investigative Site
      • Panama City, Florida, Forente stater
        • Pearl Investigative Site
      • Pensacola, Florida, Forente stater
        • Pearl Investigative Site
      • St Petersburg, Florida, Forente stater
        • Pearl Investigative Site
      • Tampa, Florida, Forente stater
        • Pearl Investigative Site
      • Winter Park, Florida, Forente stater
        • Pearl Investigative Site
    • Georgia
      • Atlanta, Georgia, Forente stater
        • Pearl Investigative Site
      • Austell, Georgia, Forente stater
        • Pearl Investigative Site
      • Columbus, Georgia, Forente stater
        • Pearl Investigative Site
      • Duluth, Georgia, Forente stater
        • Pearl Investigative Site
      • Gainesville, Georgia, Forente stater
        • Pearl Investigative Site
    • Idaho
      • Couer d'aline, Idaho, Forente stater
        • Pearl Investigative Site
    • Illinois
      • Champaign, Illinois, Forente stater
        • Pearl Investigative Site
      • Evanston, Illinois, Forente stater
        • Pearl Investigative Site
      • Peoria, Illinois, Forente stater
        • Pearl Investigative Site
      • River Forest, Illinois, Forente stater
        • Pearl Investigative Site
    • Indiana
      • Avon, Indiana, Forente stater
        • Pearl Investigative Site
      • Evansville, Indiana, Forente stater
        • Pearl Investigative Site
      • South Bend, Indiana, Forente stater
        • Pearl Investigative Site
    • Iowa
      • Iowa City, Iowa, Forente stater
        • Pearl Investigative Site
    • Kansas
      • Olathe, Kansas, Forente stater
        • Pearl Investigative Site
      • Topeka, Kansas, Forente stater
        • Pearl Investigative Site
    • Kentucky
      • Louisville, Kentucky, Forente stater
        • Pearl Investigative Site
    • Louisiana
      • Lafayette, Louisiana, Forente stater
        • Pearl Investigative Site
      • Sunset, Louisiana, Forente stater
        • Pearl Investigative Site
    • Maryland
      • Hollywood, Maryland, Forente stater
        • Pearl Investigative Site
    • Michigan
      • Livonia, Michigan, Forente stater
        • Pearl Investigative Site
      • Southfield, Michigan, Forente stater
        • Pearl Investigative Site
    • Minnesota
      • Edina, Minnesota, Forente stater
        • Pearl Investigative Site
      • Fridley, Minnesota, Forente stater
        • Pearl Investigative Site
      • Minneapolis, Minnesota, Forente stater
        • Pearl Investigative Site
      • Woodbury, Minnesota, Forente stater
        • Pearl Investigative Site
    • Missouri
      • Chesterfield, Missouri, Forente stater
        • Pearl Investigative Site
      • Springfield, Missouri, Forente stater
        • Pearl Investigative Site
      • St Louis, Missouri, Forente stater
        • Pearl Investigative Site
    • Nebraska
      • Bellvue, Nebraska, Forente stater
        • Pearl Investigative Site
      • Omaha, Nebraska, Forente stater
        • Pearl Investigative Site
    • Nevada
      • Las Vegas, Nevada, Forente stater
        • Pearl Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, Forente stater
        • Pearl Investigative Site
    • New York
      • Corning, New York, Forente stater
        • Pearl Investigative Site
    • North Carolina
      • Burlington, North Carolina, Forente stater
        • Pearl Investigative Site
      • Charlotte, North Carolina, Forente stater
        • Pearl Investigative Site
      • Greensboro, North Carolina, Forente stater
        • Pearl Investigative Site
      • Huntersville, North Carolina, Forente stater
        • Pearl Investigative Site
      • Mooresville, North Carolina, Forente stater
        • Pearl Investigative Site
      • Raleigh, North Carolina, Forente stater
        • Pearl Investigative Site
      • Wilmington, North Carolina, Forente stater
        • Pearl Investigative Site
      • Winston-Salem, North Carolina, Forente stater
        • Pearl Investigative Site
    • Ohio
      • Cincinnati, Ohio, Forente stater
        • Pearl Investigative Site
      • Dayton, Ohio, Forente stater
        • Pearl Investigative Site
    • Oregon
      • Bend, Oregon, Forente stater
        • Pearl Investigative Site
      • Brandon, Oregon, Forente stater
        • Pearl Investigative Site
      • Medford, Oregon, Forente stater
        • Pearl Investigative Site
      • Portland, Oregon, Forente stater
        • Pearl Investigative Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater
        • Pearl Investigative Site
      • Pittsburgh, Pennsylvania, Forente stater
        • Pearl Investigative Site
    • South Carolina
      • Charleston, South Carolina, Forente stater
        • Pearl Investigative Site
      • Easley, South Carolina, Forente stater
        • Pearl Investigative Site
      • Gaffney, South Carolina, Forente stater
        • Pearl Investigative Site
      • Murrells Inlet, South Carolina, Forente stater
        • Pearl Investigative Site
      • Rock Hill, South Carolina, Forente stater
        • Pearl Investigative Site
      • Spartanburg, South Carolina, Forente stater
        • Pearl Investigative Site
    • South Dakota
      • Rapid City, South Dakota, Forente stater
        • Pearl Investigative Site
    • Tennessee
      • Bristol, Tennessee, Forente stater
        • Pearl Investigative Site
      • Johnson City, Tennessee, Forente stater
        • Pearl Investigative Site
      • Kingsport, Tennessee, Forente stater
        • Pearl Investigative Site
    • Texas
      • Austin, Texas, Forente stater
        • Pearl Investigative Site
      • Houston, Texas, Forente stater
        • Pearl Investigative Site
      • Huntsville, Texas, Forente stater
        • Pearl Investigative Site
      • Longview, Texas, Forente stater
        • Pearl Investigative Site
      • New Braunfels, Texas, Forente stater
        • Pearl Investigative Site
      • San Antonio, Texas, Forente stater
        • Pearl Investigative Site
    • Utah
      • Midvale, Utah, Forente stater
        • Pearl Investigative Site
      • Salt Lake City, Utah, Forente stater
        • Pearl Investigative Site
    • Vermont
      • South Burlington, Vermont, Forente stater
        • Pearl Investigative Site
    • Virginia
      • Abingdon, Virginia, Forente stater
        • Pearl Investigative Site
      • Richmond, Virginia, Forente stater
        • Pearl Investigative Site
    • Washington
      • Spokane, Washington, Forente stater
        • Pearl Investigative Site
      • Tacoma, Washington, Forente stater
        • Pearl Investigative Site
    • West Virginia
      • Morgantown, West Virginia, Forente stater
        • Pearl Investigative Site
    • Wisconsin
      • West Allis, Wisconsin, Forente stater
        • Pearl Investigative Site
  • New Zealand
      • Tauranga, New Zealand
        • Pearl Investigative Site
    • Aukland
      • Otahuhu, Aukland, New Zealand
        • Pearl Investigative Site
    • Dunedin
      • Caversham, Dunedin, New Zealand
        • Pearl Investigative Site
    • East Aukland
      • Greenlabe, East Aukland, New Zealand
        • Pearl Investigative Site
    • Waikato
      • Hamilton, Waikato, New Zealand
        • Pearl Investigative Site
    • Wellington
      • Newtown, Wellington, New Zealand
        • Pearl Investigative Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Key Inclusion Criteria:

  • Participant in/completion of previous 24-week PINNACLE Phase III Trial.
  • Male or female subjects at least 40 years of age and no older than 80 at Visit 1.
  • Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
  • Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
  • Subjects with FEV1/forced vital capacity (FVC) ratio of <0.70 and FEV1 <80% predicted normal and ≥750 mL if FEV1 <30% of predicted normal value.
  • Subjects willing and, in the opinion of the investigator, able to adjust current COPD therapy as required by the protocol

Key Exclusion Criteria:

  • Significant diseases other than COPD, i.e. disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study
  • Current diagnosis of asthma or alpha-1 antitrypsin deficiency
  • Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea
  • Hospitalized due to poorly controlled COPD within 3 months prior to screening or during the Screening Period
  • Poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to screening or during the Screening Period
  • Lower respiratory tract infections that required antibiotics within 6 weeks prior to screening or during the Screening Period
  • Unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 12 months of enrollment.
  • Recent history of acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft within the past three months
  • Congestive heart failure (CHF) New York Heart Association (NYHA) Class III/IV)
  • Clinically significant abnormal 12-lead electrocardiogram (ECG)
  • Abnormal liver function tests defined as alanine transaminase (ALT), aspartate transaminanse (AST), or total bilirubin ≥ 1.5 times upper limit of normal at Visit 1 and on repeat testing
  • Cancer not in complete remission for at least five years
  • History of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, lactose/milk protein or any component of the MDI

Other protocol-defined inclusion/exclusion criteria may apply

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Åpen etikett tiotropiumbromid inhalasjonspulver
Åpen etikett tiotropiumbromid inhalasjonspulver (Spiriva® Handihaler®)
Legemiddel: Open-label tiotropium bromide inhalation (Spiriva® Handihaler®)
Taken as 1 capsule daily containing 18 μg of open-label tiotropium via the Handihaler dry powder inhaler (DPI)
Eksperimentell: GFF MDI (PT003)
Legemiddel: GFF MDI (PT 003)
GFF MDI administered as two puffs BID
Eksperimentell: GP MDI (PT001)
Legemiddel: GP MDI (PT001)
Fastlege MDI administrert som to drag BID
Eksperimentell: FF MDI (PT005)
Legemiddel: FF MDI (PT005)
FF MDI administrert som to drag BID

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks
Tidsramme: Baseline and Weeks 2 to 52
Change From Baseline in Morning Pre-Dose Trough FEV1 Over 52 Weeks as a Model-Based Average (ITT Population). FEV1 was assessed at multiple time points post-baseline, and a model-based average of all visits starting from Week 2 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.
Baseline and Weeks 2 to 52

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Self-Administered Computerized (SAC) TDI Focal Score Over 52 Weeks
Tidsramme: Baseline and Weeks 4 to 52
SAC TDI focal score over 52 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9.
Baseline and Weeks 4 to 52
Peak Change From Baseline in FEV1 Within 2 Hrs Post-dosing
Tidsramme: Baseline and Weeks 2 to 52
Peak change from Baseline FEV1 Over 52 Weeks is a Model-Based Average (ITT Population). Peak FEV1 was assessed at multiple visits post-baseline, and a model-based average of all visits starting from Week 2 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average Peak FEV1 post-baseline.
Baseline and Weeks 2 to 52
Change From Baseline in SGRQ Total Score
Tidsramme: Baseline and Weeks 12 to 52
The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (best possible health status) to 100 (worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life. SGRQ Total Score was assessed at multiple visits post-baseline, and a model-based average of all visits starting from Week 12 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average SGRQ Total Score post-baseline.
Baseline and Weeks 12 to 52
Change From Baseline in Average Daily Rescue Ventolin Use
Tidsramme: Baseline through Week 52
Subjects recorded in their diary the number of puffs of rescue Ventolin HFA taken on each study day. The subject's average daily number of puffs of rescue Ventolin HFA was calculated over the entire 52-week treatment period. Missing values were ignored in both the numerator and denominator. Diary data recorded during the last 7 days of the 10-14 day screening period were used to calculate the baseline average. Change in rescue Ventolin HFA use was calculated by subtracting the baseline average from the 52-week average.
Baseline through Week 52

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pearl Therapeutics, Inc.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2013

Primær fullføring (Faktiske)

1. mars 2015

Studiet fullført (Faktiske)

1. mars 2015

Datoer for studieregistrering

Først innsendt

18. oktober 2013

Først innsendt som oppfylte QC-kriteriene

22. oktober 2013

Først lagt ut (Anslag)

28. oktober 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. mars 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. februar 2017

Sist bekreftet

1. februar 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PT003008-00

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere