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

• Register: EUCTR
• Last refreshed on: 17 November 2014
• Main ID: EUCTR2012-005184-27-DE
• Date of registration: 18/06/2013
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International NV
• Public title: An Effectiveness and Safety Study of Inhaled JNJ 49095397 in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease.
• Scientific 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.
• Date of first enrolment: 04/09/2013
• Target sample size: 200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005184-27
• Study type: Interventional clinical trial of medicinal product
• Study design: 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

Countries of recruitment

Belgium, Germany, Hungary, Netherlands, Poland

Contacts

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International NV

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International NV

Key inclusion & exclusion 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:
-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), noninvasive 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

Health Condition(s) or Problem(s) studied

Moderate to Severe Chronic Obstructive Pulmonary Disease
MedDRA version: 17.1 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

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

Primary Outcome(s)

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.

Timepoint(s) of evaluation of this end point: Baseline (Week 0) to Week 12

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.

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 Outcome(s)

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

Secondary ID(s)

2012-005184-27-BE

49095397OPD2001

Source(s) of Monetary Support

Janssen Research & Development, LLC