Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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7 October 2014 |
Main ID: |
EUCTR2012-005184-27-HU |
Date of registration:
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28/08/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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An Effectiveness and Safety Study of Inhaled JNJ 49095397 in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease.
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Scientific title:
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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. |
Date of first enrolment:
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11/11/2013 |
Target sample size:
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200 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005184-27 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Countries of recruitment
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Belgium
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Germany
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Hungary
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Netherlands
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Poland
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Contacts
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Name:
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Clinical Registry Group
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Address:
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Archimedesweg 29-2333CM
2333CM
Leiden
Netherlands |
Telephone:
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+31(0)715242166 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International NV |
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Name:
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Clinical Registry Group
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Address:
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Archimedesweg 29-2333CM
2333CM
Leiden
Netherlands |
Telephone:
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+31(0)715242166 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International NV |
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Key inclusion & exclusion criteria
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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: -Has another pulmonary disease (eg, asthma) or an active infection (eg, tuberculosis)
-Has experienced life-threatening COPD (eg, requiring intensive care unit [ICU] admission, intubation, or long-term non-invasive ventilation).
Short-term (less than five days), non-invasive ventilation during a hospitalization for an acute exacerbation of COPD is permitted, provided that non-invasive ventilation was not continued at home.
- 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.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
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Moderate to Severe Chronic Obstructive Pulmonary
Disease MedDRA version: 16.1
Level: PT
Classification code 10009033
Term: Chronic obstructive pulmonary disease
System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
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Intervention(s)
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Product Name: JNJ 49095397 Product Code: JNJ 49095397 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Not Assigned CAS Number: 1220626-82-3 Other descriptive name: RV568, JNJ-49095397-AAA Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 400- Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the placebo: Inhalation use
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Primary Outcome(s)
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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.
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Timepoint(s) of evaluation of this end point: Baseline (Week 0) to Week 12
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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.
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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.
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Secondary Outcome(s)
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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.
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Timepoint(s) of evaluation of this end point: Please refere to section E. 5.2
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Secondary ID(s)
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2012-005184-27-BE
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49095397OPD2001
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Source(s) of Monetary Support
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Janssen Research & Development, LLC
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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