A Study to Evaluate the Effectiveness and Safety of CNTO6785 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
6 juni 2016 uppdaterad av: Janssen Research & Development, LLC
A Randomized, Placebo Controlled Double-Blind, Multi-Center, Phase II Study to Assess the Efficacy and Safety of CNTO6785 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
The purpose of the study is to evaluate the effect of CNTO6785 compared with placebo in participants with moderate to severe Chronic Obstructive Pulmonary Disease.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This is a multi-center, randomized (study medication is assigned by chance), placebo-controlled (effect of the study medication will be compared with the effect of placebo [inactive substance]), double-blind (neither physician nor participant knows the treatment that the participant receives), parallel-group study (each group of participants will be treated at the same time).
This study consists of 3 phases: a screening phase (within 3 weeks prior to the start of study medication), a treatment phase (12 weeks), and a follow-up phase (12 weeks after the last administration of study medication).
Approximately 170 participants will be enrolled in this study to receive CNTO6785 or placebo in 1:1 ratio.
Safety will be evaluated by the assessment of adverse events, vital signs, 12-lead electrocardiogram, physical examination, early detection of active tuberculosis, and clinical laboratory tests which will be monitored throughout the study.
The total duration of study participation for a participant will be 30 weeks.
Studietyp
Interventionell
Inskrivning (Faktisk)
187
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Seoul, Korea, Republiken av
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Suwon, Korea, Republiken av
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Wonju-Si, Korea, Republiken av
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Batu Caves, Malaysia
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Kota Bharu, Malaysia
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Kuala Lumpur, Malaysia
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Krakow, Polen
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Lodz, Polen
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Poznan, Polen
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Poznań, Polen
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Wroclaw, Polen
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Barnaul, Ryska Federationen
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Ekaterinburg, Ryska Federationen
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Kemerovo, Ryska Federationen
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Novosibirsk, Ryska Federationen
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Saint Petersberg, Ryska Federationen
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Saint-Petersberg, Ryska Federationen
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Saratov, Ryska Federationen
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St. Petersburg, Ryska Federationen
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Yaroslavl, Ryska Federationen
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New Taipei City, Taiwan
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Taipei, Taiwan
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Brno, Tjeckien
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Jindrichuv Hradec, Tjeckien
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Karlovy Vary, Tjeckien
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Melnik, Tjeckien
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Praha 5 - Radotin, Tjeckien
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Praha 8, Tjeckien
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Strakonice, Tjeckien
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Berlin, Tyskland
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Dresden, Tyskland
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Frankfurt, Tyskland
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Grosshansdorf, Tyskland
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Hannover, Tyskland
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Koblenz, Tyskland
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Magdeburg, Tyskland
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Ruedersdorf, Tyskland
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Balassagyarmat, Ungern
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Budapest, Ungern
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Farkasgyepü, Ungern
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Komarom, Ungern
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Létavértes, Ungern
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Mohacs, Ungern
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Nagykanizsa, Ungern
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Zalaegerszeg-P Zva N/A, Ungern
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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 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion criteria:
- Moderate to severe Chronic Obstructive Pulmonary Disease (COPD) (Grade II or Grade III according to the GOLD Guidelines) with chronic bronchitis (sputum production on most days for at least 12 weeks per year for at least 2 successive years) at screening
- Persistent COPD symptoms that required repeated (greater than 1) 'as needed' use of a short acting rescue medication within 4 weeks prior to screening
- Had at least 2 COPD exacerbations requiring antibiotics and/or systemic corticosteroids in the past 2 years OR able to spontaneously produce an adequate sputum sample within 3 to 6 weeks prior to the start of study medication
- Be a current or ex-smoker who has a smoking history of at least 10 pack years at screening
- Meet tuberculosis(TB) screening criteria as: no history of latent or active TB, no signs or symptoms suggestive of active TB, have not had recent (within 3 months) close contact with a person with active TB, and no evidence of current, active TB or old, inactive TB
Exclusion criteria:
- Pulmonary disease, such as asthma, clinically significant bronchiectasis, cystic fibrosis, sarcoidosis, interstitial lung disorder, moderate or severe sleep apnea, or pulmonary hypertension at screening
- Has ever experienced life-threatening COPD, had a lung lobectomy, lung cancer surgery, lung volume reduction, or a lung transplant
- Requires oxygen therapy on a daily basis (greater than 12 hours/day) for chronic hypoxemia (inadequate level of oxygen in the blood) at screening
- Has received any live, attenuated viral or bacterial vaccines within 3 months prior to screening or is expected to receive any live attenuated vaccinations during the study or up to 6 months after the last administration of study medication
- Positive serology to human immunodeficiency virus 1 or 2, hepatitis B virus, or hepatitis C virus
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: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Placebo-jämförare: Placebo
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Sterile, 5 percent dextrose will be used as the placebo in this study.
Placebo will be administered by intravenous infusion on Weeks 0, 2, 4, 8 and 12.
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Experimentell: CNTO 6785
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CNTO 6785 (6 mg/kg) will be administered by intravenous (into a vein) infusion on Weeks 0, 2, 4, 8 and 12. Participants who weigh more than 100 kg will receive a dose of 600 mg of CNTO 6785.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Change from baseline in prebronchodilator (before taking an inhaled bronchodilator) Forced Expiratory Volume in 1 second (FEV1) at Week 16
Tidsram: Baseline (Week 0), Week 16
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FEV1 is the amount of air that can be exhaled in one second.
FEV1 will be measured by spirometry.
A positive change from baseline in FEV1 indicates improvement in lung function.
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Baseline (Week 0), Week 16
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change from baseline in postbronchodilator (after taking an inhaled bronchodilator) Forced Expiratory Volume in 1 second (FEV1) at Week 16
Tidsram: Baseline (Week 0), Week 16
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FEV1 is the amount of air that can be exhaled in one second.
FEV1 will be measured by spirometry.
A positive change from baseline in FEV1 indicates improvement in lung function.
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Baseline (Week 0), Week 16
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Change from baseline in weekly average number of occasions in a day that rescue medication is used at Week 16
Tidsram: Baseline (Week 0), Week 16
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Rescue medication is a relief medication for chronic obstructive pulmonary disease symptoms.
e.g. when patients feel breathless, chest tight, or frequent cough.
The reduction of number of the occasions indicates disease improvement with less symptoms.
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Baseline (Week 0), Week 16
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Change from baseline in EXAcerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms™ (E-RS™) at Week 16
Tidsram: Baseline (Week 0), Week 16
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E-RS is a 11-item respiratory system scoring algorithm to assess the severity of respiratory symptoms in participants with chronic obstructive pulmonary disease (COPD).
Each item has either 5 or 6 response options.
Higher score indicates more severe COPD.
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Baseline (Week 0), Week 16
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Change from baseline at Week 16 in total score of the St George's respiratory questionnaire for Chronic Obstructive Pulmonary Disease (COPD) participants (SGRQ-C)
Tidsram: Baseline (Week 0), Week 16
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SGRQ-C is a 40-item questionnaire designed to measure health impairment in participants with COPD.
SGRQ-C is divided into two components: 1) symptoms, 2) activity& impacts.
Total SGRQ-C score ranges from 0 (best) and 100 (worst).
Higher scores indicate greater health impairment.
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Baseline (Week 0), Week 16
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Samarbetspartners och utredare
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Publikationer och användbara länkar
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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 september 2015
Avslutad studie (Faktisk)
1 september 2015
Studieregistreringsdatum
Först inskickad
17 oktober 2013
Först inskickad som uppfyllde QC-kriterierna
17 oktober 2013
Första postat (Uppskatta)
21 oktober 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
8 juni 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 juni 2016
Senast verifierad
1 juni 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CR102318
- CNTO6785OPD2001 (Annan identifierare: Janssen Research & Development, LLC)
- 2012-003607-36 (EudraCT-nummer)
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 .