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

28 juni 2011 uppdaterad av: 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

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

147

Fas

  • Fas 2
  • Fas 1

Kontakter och platser

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

Studieorter

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

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.

Studieplan

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

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: Canakinumab
The dose of canakinumab (ACZ885) administered was individualized, based on the subject's weight pre-dose, and was administered via intravenous infusion.
Placebo-jämförare: 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.
Läkemedel: Placebo
Matching placebo to ACZ885 administered via intravenous infusion.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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%
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants Who Experienced Serious Adverse Events or Discontinued Due to Adverse Events
Tidsram: 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.

Samarbetspartners och utredare

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

Sponsor

Novartis

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 januari 2007

Primärt slutförande (Faktisk)

1 maj 2010

Avslutad studie (Faktisk)

1 maj 2010

Studieregistreringsdatum

Först inskickad

21 december 2007

Först inskickad som uppfyllde QC-kriterierna

21 december 2007

Första postat (Uppskatta)

28 december 2007

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

30 juni 2011

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 juni 2011

Senast verifierad

1 juni 2011

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CACZ885B2204

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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