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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 febbraio 2017 aggiornato da: 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).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

892

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 40 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Tiotropio bromuro polvere per inalazione in aperto
Polvere per inalazione di bromuro di tiotropio in aperto (Spiriva® Handihaler®)
Droga: 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)
Sperimentale: GFF MDI (PT003)
Droga: GFF MDI (PT 003)
GFF MDI administered as two puffs BID
Sperimentale: GP MDI (PT001)
Droga: GP MDI (PT001)
GP MDI somministrato come due puff BID
Sperimentale: FF MDI (PT005)
Droga: FF MDI (PT005)
FF MDI somministrato come due puff BID

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Self-Administered Computerized (SAC) TDI Focal Score Over 52 Weeks
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pearl Therapeutics, Inc.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2013

Completamento primario (Effettivo)

1 marzo 2015

Completamento dello studio (Effettivo)

1 marzo 2015

Date di iscrizione allo studio

Primo inviato

18 ottobre 2013

Primo inviato che soddisfa i criteri di controllo qualità

22 ottobre 2013

Primo Inserito (Stima)

28 ottobre 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 marzo 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 febbraio 2017

Ultimo verificato

1 febbraio 2017

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PT003008-00

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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