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

Study Overview
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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.

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

Conditions
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Asthma

Intervention / Treatment
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* Drug: JNJ-18054478
* Drug: sham comparator


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, persistant asthma, controller medications, FEV1