A Study to Evaluate the Effectiveness and Safety of CNTO6785 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
|ClinicalTrials.gov Identifier: NCT01966549|
Recruitment Status : Completed
First Posted : October 21, 2013
Last Update Posted : June 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive||Drug: CNTO 6785 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||187 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
|Experimental: CNTO 6785||
Drug: CNTO 6785
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.
|Placebo Comparator: Placebo||
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.
- Change from baseline in prebronchodilator (before taking an inhaled bronchodilator) Forced Expiratory Volume in 1 second (FEV1) at Week 16 [ Time Frame: Baseline (Week 0), Week 16 ]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.
- Change from baseline in postbronchodilator (after taking an inhaled bronchodilator) Forced Expiratory Volume in 1 second (FEV1) at Week 16 [ Time Frame: Baseline (Week 0), Week 16 ]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.
- Change from baseline in weekly average number of occasions in a day that rescue medication is used at Week 16 [ Time Frame: Baseline (Week 0), Week 16 ]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.
- Change from baseline in EXAcerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms™ (E-RS™) at Week 16 [ Time Frame: Baseline (Week 0), Week 16 ]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.
- 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) [ Time Frame: Baseline (Week 0), Week 16 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966549
|Brno, Czech Republic|
|Jindrichuv Hradec, Czech Republic|
|Karlovy Vary, Czech Republic|
|Melnik, Czech Republic|
|Praha 5 - Radotin, Czech Republic|
|Praha 8, Czech Republic|
|Strakonice, Czech Republic|
|Zalaegerszeg-P Zva N/A, Hungary|
|Korea, Republic of|
|Seoul, Korea, Republic of|
|Suwon, Korea, Republic of|
|Wonju-Si, Korea, Republic of|
|Batu Caves, Malaysia|
|Kota Bharu, Malaysia|
|Kuala Lumpur, Malaysia|
|Barnaul, Russian Federation|
|Ekaterinburg, Russian Federation|
|Kemerovo, Russian Federation|
|Novosibirsk, Russian Federation|
|Saint Petersberg, Russian Federation|
|Saint-Petersberg, Russian Federation|
|Saratov, Russian Federation|
|St. Petersburg, Russian Federation|
|Yaroslavl, Russian Federation|
|New Taipei City, Taiwan|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|