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

Johnson & Johnson (J&J)

Status and phase: Terminated; Phase 2

Conditions: Asthma

Treatments: Drug: sham comparator; Drug: JNJ-18054478

Study type: Interventional

Funder types: Industry

Identifiers

NCT00530166

18054478NAP2002

CR013087

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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26 participants in 2 patient groups

002

Experimental group

Description:

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

Treatment:

Drug: sham comparator

001

Experimental group

Description:

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

Treatment:

Drug: JNJ-18054478