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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 februari 2017 uppdaterad 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).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

892

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

40 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Inhalationspulver av tiotropiumbromid med öppen etikett
Öppen etikett tiotropiumbromid inhalationspulver (Spiriva® Handihaler®)
Läkemedel: 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)
Experimentell: GFF MDI (PT003)
Läkemedel: GFF MDI (PT 003)
GFF MDI administered as two puffs BID
Experimentell: GP MDI (PT001)
Läkemedel: GP MDI (PT001)
GP MDI administreras som två bloss BID
Experimentell: FF MDI (PT005)
Läkemedel: FF MDI (PT005)
FF MDI administreras som två bloss BID

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Self-Administered Computerized (SAC) TDI Focal Score Over 52 Weeks
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Pearl Therapeutics, Inc.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 november 2013

Primärt slutförande (Faktisk)

1 mars 2015

Avslutad studie (Faktisk)

1 mars 2015

Studieregistreringsdatum

Först inskickad

18 oktober 2013

Först inskickad som uppfyllde QC-kriterierna

22 oktober 2013

Första postat (Uppskatta)

28 oktober 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 mars 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 februari 2017

Senast verifierad

1 februari 2017

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • PT003008-00

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