Effectiveness and Safety Study for JNJ-18054478 in Asthma Patients.

June 3, 2014 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Investigate the Effect of JNJ-18054478 in Subjects With Asthma

The purpose of this study is to assess the effectiveness of JNJ-18054478 measured by the percent change from baseline in Forced Expiratory Volume in one Second (FEV1) after 12 weeks of therapy in patients with persistent asthma.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Asthma is one of the most common chronic diseases worldwide. This is a randomized (study medication assigned by chance), double-blind study (neither the physician or the patient knows which drug they are receiving, active or placebo) to Investigate the effectiveness and safety of 12 weeks of dosing with JNJ-18054478 (300 mg taken orally once daily) compared with placebo in patients with persistent asthma. The hypothesis is that the study drug will be more effective in treatment of asthma than placebo as measured by the percent change from baseline in Forced Expiratory Volume in one Second (FEV1) after 12 weeks of therapy, without any significant adverse events. Safety evaluations will include, monitoring for adverse reactions, clinical laboratory tests of blood and urine, ECGs to monitor the cardiovascular system, vital signs and physical examinations. Patients will take three capsules (100 mg) of JNJ-18054478 orally once daily for 12 weeks or placebo for the same period.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • 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

  • Costa Rica
      • San Jose, Costa Rica
  • India
      • Bangalore, India
      • Chennai, India
      • Hyderabad, India
      • Mumbai, India
      • Mysore, India
      • Vellore, India
  • United States
    • Arizona
      • Scottsdale, Arizona, United States
    • California
      • Long Beach, California, United States
      • Los Angeles, California, United States
      • Paramount, California, United States
      • San Jose, California, United States
    • Colorado
      • Colorado Springs, Colorado, United States
      • Pueblo, Colorado, United States
    • Illinois
      • Chicago, Illinois, United States
      • Normal, Illinois, United States
      • River Forest, Illinois, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • North Dartmouth, Massachusetts, United States
    • Minnesota
      • Plymouth, Minnesota, United States
    • Missouri
      • St. Louis, Missouri, United States
    • New Jersey
      • Skillman, New Jersey, United States
    • New York
      • North Syracuse, New York, United States
      • Rochester, New York, United States
    • Ohio
      • Canton, Ohio, United States
      • Cincinnati, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
      • Tulsa, Oklahoma, United States
    • Oregon
      • Lake Oswego, Oregon, United States
      • Medford, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Chester, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
    • Texas
      • Dallas, Texas, United States
    • Wisconsin
      • Madison, Wisconsin, 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

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Medically confirmed diagnosis of persistent asthma
  • Able to demonstrate reversibility of at least 12% with albuterol inhalation
  • Use of short-acting b-2 agonists for rescue >= 5 times within 2 weeks prior
  • Able to produce an FEV1 between 45 and 85% of predicted
  • Willing to perform study procedures for about 14 weeks.

Exclusion Criteria:

  • Use of inhaled corticosteroids within 4 weeks
  • Use of oral/parenteral corticosteroids within 8 weeks
  • Use of long-acting beta-2 agonists or montelukast within 2 weeks
  • History of life-threatening asthma attack within 3 months
  • Female of child bearing potential.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 002
sham comparator 3(100 mg) tablets once daily for 12 weeks
Drug: sham comparator
3(100 mg) tablets once daily for 12 weeks
Experimental: 001
JNJ-18054478 3(100 mg) tablets once daily for 12 weeks
Drug: JNJ-18054478
3(100 mg) tablets once daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The percent change from the beginning of the study in Forced Expiratory Volume in one Second (FEV1) after 12 weeks on study drug.
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The change in FEV1 after 1, 2, 4, 6, 8 and 10 weeks therapy. The change in symptoms and use of asthma rescue medication. The number of asthma attacks compared to placebo. The safety, tolerability, and blood and urine levels of JNJ-18054478
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

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

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

July 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

September 13, 2007

First Submitted That Met QC Criteria

September 13, 2007

First Posted (Estimate)

September 17, 2007

Study Record Updates

Last Update Posted (Estimate)

June 18, 2014

Last Update Submitted That Met QC Criteria

June 3, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR013087
  • 18054478NAP2002

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.

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