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Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
---|---|
Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00530166 |
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.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: JNJ-18054478 Drug: sham comparator |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Investigate the Effect of JNJ-18054478 in Subjects With Asthma |
Estimated Enrollment: | 120 |
Study Start Date: | June 2007 |
Study Completion Date: | July 2008 |
Arms | Assigned Interventions |
---|---|
001: Experimental |
Drug: JNJ-18054478
3(100 mg) tablets once daily for 12 weeks
|
002: Experimental |
Drug: sham comparator
3(100 mg) tablets once daily for 12 weeks
|
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. ( Associate Director Experimental Medicine ) |
Study ID Numbers: | CR013087, 18054478NAP2002 |
Study First Received: | September 13, 2007 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00530166 |
Health Authority: | United States: Food and Drug Administration |
FEV1 Asthma persistant asthma controller medications |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
Immune System Diseases Bronchial Diseases |