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

August 19, 2019 updated by: Janssen Research & Development, LLC

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
211

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium
      • Bruxelles, Belgium
      • Genk, Belgium
      • Kortrijk, Belgium
      • Leuven, Belgium
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
      • Edmonton, Alberta, Canada
    • Ontario
      • Hamilton, Ontario, Canada
      • Ottawa, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
      • Sainte Foy, Quebec, Canada
      • Sherbrooke, Quebec, Canada
  • Czechia
      • Prague 5, Czechia
      • Praha, Czechia
  • Germany
      • Berlin, Germany
      • Frankfurt, Germany
      • Großhansdorf, Germany
      • Hamburg, Germany
      • Lübeck, Germany
      • Mainz, Germany
  • Hungary
      • Budapest, Hungary
      • Farkasgyepü, Hungary
      • Mosonmagyaróvár, Hungary
      • Szikszó, Hungary
  • Netherlands
      • Eindhoven, Netherlands
      • Groningen, Netherlands
      • Rotterdam, Netherlands
      • Sittard / Geleen, Netherlands
      • Zwolle, Netherlands
  • Poland
      • Bialystok, Poland
      • Lodz, Poland
      • Wroclaw, Poland
  • Romania
      • Bucharest, Romania
  • Russian Federation
      • Barnaul, Russian Federation
      • Moscow, Russian Federation
      • Saint-Petersburg, Russian Federation
      • Sankt-Peterburg, Russian Federation
  • United Kingdom
      • Bristol, United Kingdom
      • Dundee, United Kingdom
      • Edinburgh, United Kingdom
      • Glasgow, United Kingdom
      • London, United Kingdom
  • United States
    • Arizona
      • Phoenix, Arizona, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
      • Charlotte, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
    • South Carolina
      • Spartanburg, South Carolina, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Placebo will be inhaled by participants once daily by using a dry powder inhaler for 12 weeks.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Prebronchodilator (preBD, before taking an inhaled bronchodilator) Percent-predicted Forced Expiratory Volume in one Second (FEV1) at Week 12
Time Frame: 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.
Baseline (Week 0) to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events
Time Frame: Up to 16 weeks
Up to 16 weeks
Change From Baseline in Postbronchodilator (postBD, after taking an inhaled bronchodilator) FEV1 at Week 12
Time Frame: 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.
Baseline (Week 0) to Week 12
Change From Baseline in Weekly Average Number of Occasions in a day that Rescue Medication is Used at Week 12
Time Frame: 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.
Baseline (Week 0) to Week 12
Change From Baseline in EXAcerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms (E-RS) at Week 12
Time Frame: 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.
Baseline (Week 0) to Week 12
Change From Baseline in the Total Score of the St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at Week 12
Time Frame: 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.
Baseline (Week 0) to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 9, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 6, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR101807
  • 49095397OPD2001 (Other Identifier: Janssen Research & Development, LLC)
  • 2012-005184-27 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings