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A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Investigate the Effect of JNJ-18054478 in Subjects With Asthma
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.
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Scottsdale, Arizona, United States
Long Beach, California, United States
Los Angeles, California, United States
Paramount, California, United States
San Jose, California, United States
Colorado Springs, Colorado, United States
Pueblo, Colorado, United States
Chicago, Illinois, United States
Normal, Illinois, United States
River Forest, Illinois, United States
Start Date
July 1, 2007
Primary Completion Date
July 1, 2008
Completion Date
July 1, 2008
Last Updated
June 18, 2014
26
ACTUAL participants
JNJ-18054478
DRUG
sham comparator
DRUG
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
NCT02327897
NCT07219173
NCT07486401
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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