An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT01867762

Collaborator

(none)

211

Enrollment

Locations

Arms

11.7

Actual Duration (Months)

4.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the effectiveness and safety of JNJ 49095397 in participants with symptomatic moderate to severe chronic obstructive pulmonary disease (COPD).

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: JNJ 49095397 Drug: Placebo	Phase 2

Detailed Description

This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study), multicenter, parallel-group (each group of participants will be treated at the same time) study. Approximately 200 participants will be randomly assigned to JNJ 49095397 or placebo in the ratio 1:1. The study consists of 3 phases: screening (3 weeks), double-blind treatment (12 weeks), and follow up (4 weeks). Safety evaluations will include assessment of adverse events, vital signs, physical examination, electrocardiograms, and clinical laboratory tests which will be monitored throughout the study. The total duration of the study for each participant will be approximately 19 weeks.

Study Design

Study Type:

Interventional

Actual Enrollment :

211 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 9, 2013

Actual Primary Completion Date :

Aug 6, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: Placebo Placebo will be inhaled by participants once daily by using a dry powder inhaler for 12 weeks.

Arm

Intervention/Treatment

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

Drug: Placebo

Placebo will be inhaled by participants once daily by using a dry powder inhaler for 12 weeks.

Outcome Measures

Primary Outcome Measures

Change From Baseline in Prebronchodilator (preBD, before taking an inhaled bronchodilator) Percent-predicted Forced Expiratory Volume in one Second (FEV1) at Week 12 [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.

Secondary Outcome Measures

Change From Baseline in Postbronchodilator (postBD, after taking an inhaled bronchodilator) FEV1 at Week 12 [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 [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 [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 [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 [Up to 16 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

Contacts and Locations

Locations

	City	State	Country
1	Phoenix	Arizona	United States
2	Saint Louis	Missouri	United States
3	Chapel Hill	North Carolina	United States
4	Charlotte	North Carolina	United States
5	Cincinnati	Ohio	United States
6	Spartanburg	South Carolina	United States
7	Antwerpen		Belgium
8	Bruxelles		Belgium
9	Genk		Belgium
10	Kortrijk		Belgium
11	Leuven		Belgium
12	Calgary	Alberta	Canada
13	Edmonton	Alberta	Canada
14	Hamilton	Ontario	Canada
15	Ottawa	Ontario	Canada
16	Toronto	Ontario	Canada
17	Montreal	Quebec	Canada
18	Sainte Foy	Quebec	Canada
19	Sherbrooke	Quebec	Canada
20	Prague 5		Czechia
21	Praha		Czechia
22	Berlin		Germany
23	Frankfurt		Germany
24	Großhansdorf		Germany
25	Hamburg		Germany
26	Lübeck		Germany
27	Mainz		Germany
28	Budapest		Hungary
29	Farkasgyepü		Hungary
30	Mosonmagyaróvár		Hungary
31	Szikszó		Hungary
32	Eindhoven		Netherlands
33	Groningen		Netherlands
34	Rotterdam		Netherlands
35	Sittard / Geleen		Netherlands
36	Zwolle		Netherlands
37	Bialystok		Poland
38	Lodz		Poland
39	Wroclaw		Poland
40	Bucharest		Romania
41	Barnaul		Russian Federation
42	Moscow		Russian Federation
43	Saint-Petersburg		Russian Federation
44	Sankt-Peterburg		Russian Federation
45	Bristol		United Kingdom
46	Dundee		United Kingdom
47	Edinburgh		United Kingdom
48	Glasgow		United Kingdom
49	London		United Kingdom