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Safety and Efficacy of Multiple Doses of Canakinumab (ACZ885) in Chronic Obstructive Pulmonary Disease (COPD) Patients

28 giugno 2011 aggiornato da: Novartis

A Randomized, Double-blind, Placebo Controlled, Exploratory Study to Assess the Safety and Efficacy of Multiple Doses of ACZ885 in Chronic Obstructive Pulmonary Disease (COPD) Patients

Was to evaluate the safety, tolerability and efficacy of multiple doses of canakinumab (ACZ885) vs. placebo when administered via intravenous infusion (IV), on pulmonary function in patients with COPD

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

147

Fase

  • Fase 2
  • Fase 1

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

  • Stati Uniti
    • California
      • Anaheim, California, Stati Uniti, 92801
        • Novartis Investigator Site
      • Los Angeles, California, Stati Uniti, 90095
        • Novartis Investigator Site
    • Florida
      • Panama City, Florida, Stati Uniti, 32405
        • Novartis Investigator Site
    • Georgia
      • Marietta, Georgia, Stati Uniti, 300060
        • Novartis Investigator Site
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21224
        • Novartis Investigator Site
    • Michigan
      • Livonia, Michigan, Stati Uniti, 48152
        • Novartis Investigator Site
    • Minnesota
      • Minneapolis, Minnesota, Stati Uniti, 55402
        • Novartis Investigator Site
    • Nebraska
      • Omaha, Nebraska, Stati Uniti, 68198-5885
        • Novartis Investigator Site
    • New York
      • Buffalo, New York, Stati Uniti, 14215
        • Novartis Investigator Site
    • South Carolina
      • Spartanburg, South Carolina, Stati Uniti, 29303
        • Novartis Investigator Site
    • Virginia
      • Richmond, Virginia, Stati Uniti, 23225
        • Novartis Investigator 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

Inclusion Criteria:

  • Male and/or female subjects from 40-80 years (inclusive) of age
  • Subjects have a clinical diagnosis of COPD
  • Smokers or Ex-smokers with a smoking history of at least 20 pack years
  • Post-bronchodilator forced expiratory volume in 1 second (FEV1 ) at screening ≤ 50% of the predicted normal value
  • Post-bronchodilator FEV1/FVC ratio < 70%
  • History of at least one treated exacerbation during the 24 months year prior to screening or C-Reactive Protein (CRP) ≥3.47 mg/L,
  • Subjects should have no concomitant other lung disease or significant concomitant medical conditions that would affect the subjects' safety when participating in the study, or that would be expected to impact on the results of the study
  • Female subjects must have been surgically sterilized at least 6 months prior to screening or must be using two forms of contraception, or postmenopausal women
  • Able to provide written informed consent prior to study participation.
  • Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion Criteria:

  • COPD exacerbation(s) requiring treatment within 4 weeks prior to first dosing
  • History of lung reduction surgery
  • Any undiagnosed nodule on chest x-ray
  • Presence of certain medical conditions as specified by the protocol
  • Subjects requiring oral or parenteral corticosteroids equivalent to > 10 mg/day or > 20 mg every other day of prednisone or prednisolone
  • Documented homozygous alpha-1 antitrypsin deficiency.
  • Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
  • Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
  • A past medical history of clinically significant electrocardiogram (ECG) abnormalities or a family history of a prolonged QT-interval syndrome.
  • A known hypersensitivity to drugs similar to the study drug.
  • History of immunocompromise, including a positive HIV test result.
  • A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
  • History of drug or alcohol abuse within the 12 months prior to screening or evidence of such abuse as indicated by the laboratory assays conducted during screening.

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: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Canakinumab
Participants received an initial dose of 1 mg/kg canakinumab (ACZ885) via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
Droga: Canakinumab
The dose of canakinumab (ACZ885) administered was individualized, based on the subject's weight pre-dose, and was administered via intravenous infusion.
Comparatore placebo: Placebo
Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
Droga: Placebo
Matching placebo to ACZ885 administered via intravenous infusion.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Lasso di tempo: Baseline, Week 25 and Week 45
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 was measured by spirometry performed at approximately the same time of day on each visit to avoid diurnal variation. All spirometry calibrations and evaluations followed the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. A positive change from baseline in FEV1 indicates improvement in lung function.
Baseline, Week 25 and Week 45
Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted
Lasso di tempo: Baseline, Week 25 and Week 45
The FEV1 percent predicted expresses FEV1 as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function.
Baseline, Week 25 and Week 45
Change From Baseline in Forced Vital Capacity (FVC)
Lasso di tempo: Baseline, Week 25 and Week 45
Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry. A positive change from baseline in FVC indicates improvement in lung function.
Baseline, Week 25 and Week 45
Change From Baseline in Slow Vital Capacity (SVC)
Lasso di tempo: Baseline, Week 25 and Week 45
Vital Capacity is the amount of air that can be forcibly exhaled from the lungs after a full inhalation. Slow Vital Capacity (SVC) test is performed by having the patient slowly and completely blow out all of the air from their lungs. A positive change from baseline in SVC indicates improvement in lung function.
Baseline, Week 25 and Week 45
Change From Baseline in Forced Expiratory Flow 25% to 75%
Lasso di tempo: Baseline, Week 25 and Week 45
The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry. A positive change from baseline in FEF indicates improvement in lung function.
Baseline, Week 25 and Week 45

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants Who Experienced Serious Adverse Events or Discontinued Due to Adverse Events
Lasso di tempo: Adverse events were collected during the 45 week treatment period and the 12 week follow-up period.
Safety was assessed by the number of participants with serious adverse events and/or adverse events leading to study discontinuation. A summary of adverse events is presented with this outcome, additional details are provided in the Adverse Events section.
Adverse events were collected during the 45 week treatment period and the 12 week follow-up period.

Collaboratori e investigatori

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

Sponsor

Novartis

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 gennaio 2007

Completamento primario (Effettivo)

1 maggio 2010

Completamento dello studio (Effettivo)

1 maggio 2010

Date di iscrizione allo studio

Primo inviato

21 dicembre 2007

Primo inviato che soddisfa i criteri di controllo qualità

21 dicembre 2007

Primo Inserito (Stima)

28 dicembre 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

30 giugno 2011

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 giugno 2011

Ultimo verificato

1 giugno 2011

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CACZ885B2204

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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