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

NCT ID: NCT00530166

Last Updated: 2014-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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002

sham comparator 3(100 mg) tablets once daily for 12 weeks

Group Type EXPERIMENTAL

sham comparator

Intervention Type DRUG

3(100 mg) tablets once daily for 12 weeks

001

JNJ-18054478 3(100 mg) tablets once daily for 12 weeks

Group Type EXPERIMENTAL

JNJ-18054478

Intervention Type DRUG

3(100 mg) tablets once daily for 12 weeks

Interventions

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JNJ-18054478

3(100 mg) tablets once daily for 12 weeks

Intervention Type DRUG

sham comparator

3(100 mg) tablets once daily for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

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

Locations

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Scottsdale, Arizona, United States

Site Status

Long Beach, California, United States

Site Status

Los Angeles, California, United States

Site Status

Paramount, California, United States

Site Status

San Jose, California, United States

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Colorado Springs, Colorado, United States

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Pueblo, Colorado, United States

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Chicago, Illinois, United States

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Normal, Illinois, United States

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River Forest, Illinois, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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North Dartmouth, Massachusetts, United States

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Plymouth, Minnesota, United States

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St Louis, Missouri, United States

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Skillman, New Jersey, United States

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North Syracuse, New York, United States

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Rochester, New York, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Lake Oswego, Oregon, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Chester, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Dallas, Texas, United States

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Madison, Wisconsin, United States

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San José, , Costa Rica

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Bangalore, , India

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Chennai, , India

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Hyderabad, , India

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Mumbai, , India

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Mysore, , India

Site Status

Vellore, , India

Site Status

Countries

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United States Costa Rica India

Other Identifiers

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18054478NAP2002

Identifier Type: -

Identifier Source: secondary_id

CR013087

Identifier Type: -

Identifier Source: org_study_id

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