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

NCT ID: NCT01867762

Last Updated: 2019-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 211 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-09
• Study Completion Date: 2014-09-01

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).

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

JNJ 49095397

Group Type: EXPERIMENTAL

JNJ 49095397

Intervention Type: DRUG

JNJ 49095397 400 microgram will be inhaled by participants once daily by using a dry powder inhaler for 12 weeks.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

JNJ 49095397

JNJ 49095397 400 microgram will be inhaled by participants once daily by using a dry powder inhaler for 12 weeks.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility 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

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Phoenix, Arizona, United States

St Louis, Missouri, United States

Chapel Hill, North Carolina, United States

Charlotte, North Carolina, United States

Cincinnati, Ohio, United States

Spartanburg, South Carolina, United States

Antwerp, , Belgium

Brussels, , Belgium

Genk, , Belgium

Kortrijk, , Belgium

Leuven, , Belgium

Calgary, Alberta, Canada

Edmonton, Alberta, Canada

Hamilton, Ontario, Canada

Ottawa, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Sainte-Foy, Quebec, Canada

Sherbrooke, Quebec, Canada

Prague, , Czechia

Berlin, , Germany

Frankfurt, , Germany

Großhansdorf, , Germany

Hamburg, , Germany

Lübeck, , Germany

Mainz, , Germany

Budapest, , Hungary

Farkasgyepü, , Hungary

Mosonmagyaróvár, , Hungary

Szikszó, , Hungary

Eindhoven, , Netherlands

Groningen, , Netherlands

Rotterdam, , Netherlands

Sittard / Geleen, , Netherlands

Zwolle, , Netherlands

Bialystok, , Poland

Lodz, , Poland

Wroclaw, , Poland

Bucharest, , Romania

Barnaul, , Russia

Moscow, , Russia

Saint Petersburg, , Russia

Bristol, , United Kingdom

Dundee, , United Kingdom

Edinburgh, , United Kingdom

Glasgow, , United Kingdom

London, , United Kingdom

Countries

United States; Belgium; Canada; Czechia; Germany; Hungary; Netherlands; Poland; Romania; Russia; United Kingdom

Other Identifiers

49095397OPD2001

Identifier Type: OTHER

Identifier Source: secondary_id

2012-005184-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR101807

Identifier Type: -

Identifier Source: org_study_id