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|
|Actual Primary Completion Date :||August 2014|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|