Safety and Efficacy of Multiple Doses of Canakinumab (ACZ885) in Chronic Obstructive Pulmonary Disease (COPD) Patients
28. juni 2011 opdateret af: 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
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
147
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Anaheim, California, Forenede Stater, 92801
- Novartis Investigator Site
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Los Angeles, California, Forenede Stater, 90095
- Novartis Investigator Site
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Florida
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Panama City, Florida, Forenede Stater, 32405
- Novartis Investigator Site
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Georgia
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Marietta, Georgia, Forenede Stater, 300060
- Novartis Investigator Site
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Maryland
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Baltimore, Maryland, Forenede Stater, 21224
- Novartis Investigator Site
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Michigan
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Livonia, Michigan, Forenede Stater, 48152
- Novartis Investigator Site
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55402
- Novartis Investigator Site
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68198-5885
- Novartis Investigator Site
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New York
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Buffalo, New York, Forenede Stater, 14215
- Novartis Investigator Site
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South Carolina
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Spartanburg, South Carolina, Forenede Stater, 29303
- Novartis Investigator Site
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Virginia
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Richmond, Virginia, Forenede Stater, 23225
- Novartis Investigator Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
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The dose of canakinumab (ACZ885) administered was individualized, based on the subject's weight pre-dose, and was administered via intravenous infusion.
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Placebo komparator: 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.
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Matching placebo to ACZ885 administered via intravenous infusion.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Tidsramme: Baseline, Week 25 and Week 45
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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.
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Baseline, Week 25 and Week 45
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Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted
Tidsramme: Baseline, Week 25 and Week 45
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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.
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Baseline, Week 25 and Week 45
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Change From Baseline in Forced Vital Capacity (FVC)
Tidsramme: Baseline, Week 25 and Week 45
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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.
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Baseline, Week 25 and Week 45
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Change From Baseline in Slow Vital Capacity (SVC)
Tidsramme: Baseline, Week 25 and Week 45
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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.
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Baseline, Week 25 and Week 45
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Change From Baseline in Forced Expiratory Flow 25% to 75%
Tidsramme: Baseline, Week 25 and Week 45
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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.
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Baseline, Week 25 and Week 45
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants Who Experienced Serious Adverse Events or Discontinued Due to Adverse Events
Tidsramme: Adverse events were collected during the 45 week treatment period and the 12 week follow-up period.
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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.
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Adverse events were collected during the 45 week treatment period and the 12 week follow-up period.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2007
Primær færdiggørelse (Faktiske)
1. maj 2010
Studieafslutning (Faktiske)
1. maj 2010
Datoer for studieregistrering
Først indsendt
21. december 2007
Først indsendt, der opfyldte QC-kriterier
21. december 2007
Først opslået (Skøn)
28. december 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
30. juni 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. juni 2011
Sidst verificeret
1. juni 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CACZ885B2204
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