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

Phase 2

Terminated

• Conditions: Asthma
• Interventions: Drug: JNJ-18054478; Drug: sham comparator

• Registration Number: NCT00530166
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary

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

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 Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-09-13
• Study First Submitted QC: 2007-09-13
• Study First Posted: 2007-09-17
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Disposition First Submitted: 2011-06-01
• Disposition First Submitted QC: 2011-06-01
• Disposition First Posted: 2011-06-07
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-03
• Last Update Posted: 2014-06-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
001	JNJ-18054478	JNJ-18054478 3(100 mg) tablets once daily for 12 weeks
002	sham comparator	sham comparator 3(100 mg) tablets once daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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