An Effectiveness and Safety Study of Inhaled JNJ 49095397 in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease.

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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005184-27-GB

Enrollment

200

Registered

2013-06-17

Start date

2013-10-21

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Severe Chronic Obstructive Pulmonary Disease MedDRA version: 20.0 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: JNJ 49095397 Product Code: JNJ 49095397 Pharmaceutical Form: Inhalation powder INN or Proposed INN: Not Assigned CAS Numbe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Men and women of non-child-bearing potential, Global Initiative for Chronic Obstructive Lung Disease (GOLD 2 or 3), forced expiratory volume in one second (FEV1) greater than or equal to 40 less than 80 percent predicted, FEV1/ forced vital capacity (FVC) ratio less than 0.7 - Clinical history of chronic bronchitis. Either two chronic obstructive pulmonary disease (COPD) exacerbations in past two years or ability to produce a spontaneous sputum sample, treated with long-acting beta-2 agonist (LABA)/ long-acting muscarinic antagonists (LAMA), with or without inhaled corticosteroids for at least 12 weeks prior to study entry - Smoker or ex-smoker with at least a 10 pack-year history - No COPD exacerbation that requires change in COPD maintenance medications during the screening period - Not experienced a significant worsening of COPD based on clinical symptoms and by investigations during screening period. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: -Has another pulmonary disease (eg, asthma) or an active infection (eg, tuberculosis) -Has ever experienced life-threatening COPD (eg, requiring intensive care unit [ICU]) - Has right heart failure or oxygen saturation less than 90 percent at rest on room air at screening or requires oxygen therapy on a daily basis for chronic hypoxemia (deficiency of oxygen in blood) - History of significant disease or medical illness within 12 months prior to screening - Positive serology to human immunodeficiency virus (HIV)-1 or HIV-2, hepatitis B virus, or hepatitis C virus at screening.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to assess the efficacy (as measured by change from baseline in prebronchodilator [preBD] percent predicted FEV1) of JNJ-49095397 compared with placebo in subjects with symptomatic moderate (GOLD Grade II) to severe (GOLD Grade III) COPD. ; Secondary Objective: The secondary objectives are: •To assess the effect of JNJ-49095397 on additional lung function parameters, health-related quality of life, rescue medication usage, and COPD symptoms in subjects with symptomatic moderate to severe COPD. •To assess the safety and tolerability of JNJ-49095397 compared with placebo in subjects with symptomatic moderate to severe COPD. •To characterize the steady-state PK of JNJ-49095397 in subjects with symptomatic moderate to severe COPD. ; Primary end point(s): The Primary End Point is: Change From Baseline in Prebronchodilator (preBD, before taking an inhaled bronchodilator) Percent-predicted Forced Expiratory Volume in one Second (FEV1) at Week 12. ;Timepoint(s) of evaluation of this end point: Baseline (Week 0) and Week 12	—

Measure

Time frame

Main Objective: The primary objective is to assess the efficacy (as measured by change from baseline in prebronchodilator [preBD] percent predicted FEV1) of JNJ-49095397 compared with placebo in subjects with symptomatic moderate (GOLD Grade II) to severe (GOLD Grade III) COPD. ; Secondary Objective: The secondary objectives are: •To assess the effect of JNJ-49095397 on additional lung function parameters, health-related quality of life, rescue medication usage, and COPD symptoms in subjects with symptomatic moderate to severe COPD. •To assess the safety and tolerability of JNJ-49095397 compared with placebo in subjects with symptomatic moderate to severe COPD. •To characterize the steady-state PK of JNJ-49095397 in subjects with symptomatic moderate to severe COPD. ; Primary end point(s): The Primary End Point is: Change From Baseline in Prebronchodilator (preBD, before taking an inhaled bronchodilator) Percent-predicted Forced Expiratory Volume in one Second (FEV1) at Week 12. ;Timepoint(s) of evaluation of this end point: Baseline (Week 0) and Week 12

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Secondary

Measure	Time frame
Secondary end point(s): The Secondary End Point is: -Change From Baseline in Postbronchodilator (postBD, after taking an inhaled bronchodilator) FEV1 at Week 12. -Change From Baseline in Weekly Average Number of Occasions in a day that Rescue Medication is Used at Week 12. -Change From Baseline in EXAcerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms (E-RS) at Week 12. -Change From Baseline in the Total Score of the St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at Week 12. ;Timepoint(s) of evaluation of this end point: Please refere to section E. 5.2	—

Measure

Time frame

Secondary end point(s): The Secondary End Point is: -Change From Baseline in Postbronchodilator (postBD, after taking an inhaled bronchodilator) FEV1 at Week 12. -Change From Baseline in Weekly Average Number of Occasions in a day that Rescue Medication is Used at Week 12. -Change From Baseline in EXAcerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms (E-RS) at Week 12. -Change From Baseline in the Total Score of the St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at Week 12. ;Timepoint(s) of evaluation of this end point: Please refere to section E. 5.2

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Countries

Belgium, Czech Republic, Germany, Hungary, Netherlands, Poland, Romania, United Kingdom

Contacts

Public ContactClinical Registry Group

Janssen-Cilag International NV

ClinicalTrialsEU@its.jnj.com+31(0)715242166

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026