An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
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|ClinicalTrials.gov Identifier: NCT01867762|
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : September 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Drug: JNJ 49095397 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||211 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 2, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of Inhaled JNJ 49095397 (RV568) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease|
|Study Start Date :||September 2013|
|Primary Completion Date :||August 2014|
|Study Completion Date :||September 2014|
|Experimental: JNJ 49095397||
Drug: JNJ 49095397
JNJ 49095397 400 microgram will be inhaled by participants once daily by using a dry powder inhaler for 12 weeks.
|Placebo Comparator: Placebo||
Placebo will be inhaled by participants once daily by using a dry powder inhaler for 12 weeks.
- Change From Baseline in Prebronchodilator (preBD, before taking an inhaled bronchodilator) Percent-predicted Forced Expiratory Volume in one Second (FEV1) at Week 12 [ Time Frame: Baseline (Week 0) to Week 12 ]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 (postBD, after taking an inhaled bronchodilator) FEV1 at Week 12 [ Time Frame: Baseline (Week 0) to Week 12 ]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 12 [ Time Frame: Baseline (Week 0) to Week 12 ]Use of inhaled rescue medication (expressed as the number of occasions) taken on a schedule and/or for control of symptoms will be recorded twice daily.
- Change From Baseline in EXAcerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms (E-RS) at Week 12 [ Time Frame: Baseline (Week 0) to Week 12 ]E-RS is an 11-items 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 in the Total Score of the St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at Week 12 [ Time Frame: Baseline (Week 0) to Week 12 ]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.
- Number of participants with adverse events [ Time Frame: Up to 16 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867762
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|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|